Monitor, Breathing Frequency

FDA product code BZQ · 174 cleared devices

Class 2 Anesthesiology

Regulation: 21 CFR 868.2375
Review panel: AN
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-08-11 – 2026-06-25

BZQ 2026-06-25

BedDot (G1)

Applicant Intelligent Dots, LLC

K number K253274

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BZQ 2026-06-11

Respiration Rate algorithm

Applicant Edwards Lifesciences, LLC

K number K251326

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BZQ 2025-09-26

Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)

Applicant Linshom Medical, Inc.

K number K250093

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BZQ 2025-08-05

Respiree Cardio- Respiratory Monitor System

Applicant Respiree Pte, Ltd.

K number K250934

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BZQ 2025-06-27

RTMsense Respiratory Monitoring System

Applicant Rtm Vital Signs, LLC

K number K243183

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BZQ 2025-04-09

FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)

Applicant Faceheart Corp.

K number K243966

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BZQ 2025-04-04

Philips VSC-MEDlib

Applicant Philips Medical Systems Nederland B.V.

K number K242001

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BZQ 2025-03-28

Makani Science™ Respiration Monitoring System

Applicant Makani Science, Inc.

K number K233953

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BZQ 2025-02-28

Airmod

Applicant Heroic Faith International , Ltd.

K number K242798

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BZQ 2024-09-11

Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)

Applicant Linshom Medical, Inc.

K number K240271

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BZQ 2023-03-08

Respiree Cardio-Respiratory Monitor

Applicant Respiree Pte, Ltd.

K number K223681

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BZQ 2022-12-15

Dozee VS

Applicant Turtle Shell Technologies Private Limited

K number K221555

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BZQ 2022-11-18

Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense

Applicant Baxter Healthcare Corproration

K number K223246

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BZQ 2022-10-07

RespiraSense

Applicant Pmd Solutions

K number K220111

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BZQ 2021-11-23

Breathe Easy Mobile Respiratory Monitor (MRM)

Applicant Sound Life Sciences, Inc.

K number K211387

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BZQ 2021-03-04

Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation

Applicant Hill-Rom, Inc.

K number K202018

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BZQ 2020-06-24

The C100 Contactless Breathing Monitor

Applicant Circadia Technologies, Ltd.

K number K200445

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BZQ 2020-01-30

Linshom Respiratory Monitoring Device (LRMD)

Applicant Linshom Management, LLC

K number K190734

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BZQ 2019-12-19

The RHEA Vital Sign Vigilance System

Applicant Shenzhen Fiber Medical Technology Co. , Ltd.

K number K190775

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BZQ 2018-09-05

Masimo Acoustic Respiration Sensors, infant and neonate

Applicant Masimo Corporation

K number K173976

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BZQ 2018-05-07

Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation

Applicant Hill-Rom, Inc.

K number K180079

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BZQ 2018-01-04

EarlySense Bed Sensing Unit

Applicant Earlysense, Ltd.

K number K171836

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BZQ 2016-05-06

EarlySense Insight Sytem

Applicant Earlysense, Ltd.

K number K152911

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BZQ 2016-03-10

Thora-3Di, Model T-01

Applicant Pneumacare Limited

K number K151940

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BZQ 2013-12-26

NEUROVISION MEDICAL MOTION SENSOR

Applicant Neurovision Medical Products, Inc.

K number K130570

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BZQ 2013-12-18

EARLYSENSE

Applicant Earlysense, Ltd.

K number K131379

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BZQ 2013-04-12

NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO

Applicant Philips Medizin Systeme Boeblingen GmbH

K number K122223

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BZQ 2012-06-08

EARLYSENSE (EVERON) SYSTEM

Applicant Earlysense, Ltd.

K number K120465

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BZQ 2012-03-15

COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0

Applicant Covidien

K number K111933

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BZQ 2011-07-21

SLEEPMINDER BREATHING FREQUENCY INDICATOR

Applicant Biancamed Limited

K number K103631

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BZQ 2010-06-23

KAI SPOT MODEL KMS 200

Applicant Kai Medical, Inc.

K number K100773

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BZQ 2010-05-24

EVERON 1.0

Applicant Earlysense, Ltd.

K number K092062

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BZQ 2009-11-24

PNEUMOTHERML, MODEL: 5800

Applicant Salter Labs

K number K092685

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BZQ 2009-06-05

KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100

Applicant Kai Sensors, Inc.

K number K090273

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BZQ 2009-03-25

EVERON

Applicant Earlysense, Ltd.

K number K082465

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BZQ 2008-07-25

SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR

Applicant Salter Labs, Division of Regulatory Affairs

K number K080922

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BZQ 2007-11-15

EARLYSENSE ES-16 SYSTEM

Applicant Earlysense, Ltd.

K number K070375

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BZQ 2007-06-13

GEREONICS ULTRA-PIEZO LIMB MOVEMENT SENSOR

Applicant Gereonics, Inc.

K number K062883

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BZQ 2005-09-30

ANDROFLOW - RESPIRATORY RATE MONITOR

Applicant Andromed, Inc.

K number K051779

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BZQ 2004-04-26

DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100

Applicant Dymedix, Inc.

K number K040605

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BZQ 2001-02-05

OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE OXIMETRY MODULE)

Applicant Optovent AB

K number K003704

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BZQ 2000-08-25

ULTIMA SMARTBELT, MODEL 0560

Applicant Braebon Medical Corp.

K number K001743

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BZQ 2000-05-11

RESPIRATORY BELT SENSOR, MODEL 6000S; LIMB MOVEMENT SENSOR, MODEL 3000S

Applicant Dymedix, Inc.

K number K001030

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BZQ 1999-04-28

GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR

Applicant Gereonics, Inc.

K number K991411

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BZQ 1999-02-08

GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR

Applicant Gereonics, Inc.

K number K983449

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BZQ 1999-02-02

OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700

Applicant Optovent, Inc.

K number K981725

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BZQ 1998-12-30

ULTIMA AIRFLOW PRESSURE SENSOR

Applicant Braebon Medical Corp.

K number K984431

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BZQ 1998-10-05

BROWSER (EVENT SOFTWARE) MODEL # 4500E

Applicant Respironics, Inc.

K number K982550

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BZQ 1998-10-05

ULTIMA AIRFLOW SENSOR, 0510

Applicant Braebon Medical Corp.

K number K981445

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BZQ 1998-09-11

ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522

Applicant Braebon Medical Corp.

K number K982216

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BZQ 1998-06-26

ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER H134

Applicant Alexander Mfg. Co.

K number K981728

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BZQ 1997-04-18

MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR

Applicant Aequitron Medical, Inc.

K number K961972

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BZQ 1997-03-06

COROMETRICS MODEL 510 AND 511 MONITOR

Applicant Ge Medical Systems Information Technologies

K number K962781

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BZQ 1996-09-17

THERMISTOR CANNULA STYLE,SINGLE ELEMENT,ADAM SHELL THERMISTOR AIRFLOW SENSOR

Applicant Pro-Tech Services, Inc.

K number K960851

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BZQ 1996-02-06

OXIFLOW DIGITAL RECORDER

Applicant Edentec Corp.

K number K953363

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BZQ 1995-07-25

MODEL 510 INFANT MONITOR

Applicant Ge Medical Systems Information Technologies

K number K943308

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BZQ 1995-06-02

MODEL 511 INFANT MONITOR

Applicant Ge Medical Systems Information Technologies

K number K942170

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BZQ 1994-11-10

SNORING SENSOR

Applicant Epm Development Systems Corp.

K number K941759

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BZQ 1994-11-10

PLM SENSOR, MODEL PLM1

Applicant Pro-Tech, Inc.

K number K940014

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BZQ 1994-06-30

MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONS

Applicant Synectics-Dantec

K number K924875

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BZQ 1994-05-17

MOVING IMAGES(TM)

Applicant Epm Information Systems, Inc.

K number K935518

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BZQ 1994-05-10

MAGNUM

Applicant Sps, Inc.

K number K932902

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BZQ 1994-01-06

ADDITION OF BUILT-IN OXYMETER TO SLEEPSCAN PROD.

Applicant Bio-Logic Systems Corp.

K number K930790

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BZQ 1994-01-05

MODEL MEDILOG RAPIDE

Applicant Oxford Medilog, Inc.

K number K923737

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BZQ 1993-10-22

EDENTEC MODEL 3710 I DIGITAL PRINTER

Applicant Edentec Corp.

K number K921819

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BZQ 1993-01-28

MRIDIAN MEDICAL SYSTEMS VENTLATOR HOSES

Applicant Merit Medical Systems, Inc.

K number K925364

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BZQ 1992-12-30

CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR

Applicant Pro-Tech, Inc.

K number K923402

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BZQ 1992-12-07

EASYFLOW

Applicant Epm Information Systems, Inc.

K number K922112

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BZQ 1992-07-02

EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170

Applicant Edentec Corp.

K number K913749

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BZQ 1992-06-25

SLEEPTRACE 2000

Applicant Areca Science Corp.

K number K911874

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BZQ 1992-04-24

SLEEPMASTER

Applicant Biomedical Monitoring Systems, Inc.

K number K911386

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BZQ 1991-08-16

MEDICAL SAFETY CABLE AND LEAD SYSTEM

Applicant Medtronic Vascular

K number K912415

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BZQ 1991-07-10

SLEEP I/T-5 AND SLEEP I/T-8

Applicant Cns, Inc.

K number K904432

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BZQ 1991-06-20

MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON

Applicant Edentec Corp.

K number K905575

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BZQ 1991-04-26

MICROTRAPPER/MICRODIGITRAPPER, MODIFICATION

Applicant Synectics-Dantec

K number K905520

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BZQ 1991-04-10

RESPIRATION/HEART RATE MONITOR MODEL 9500/9550

Applicant Aequitron Medical, Inc.

K number K903020

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BZQ 1991-03-29

RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL

Applicant Non-Invasive Monitoring Systems, Inc.

K number K903011

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BZQ 1991-03-05

SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM

Applicant Simplex Medical Systems, Inc.

K number K904396

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BZQ 1990-12-28

RESP-EZ(TM) RESPIRATORY MONITORING BELT

Applicant Epm Information Systems, Inc.

K number K903300

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BZQ 1990-08-17

MODEL 900S APNEA/HEART MONITOR

Applicant Healthdyne, Inc.

K number K903287

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BZQ 1990-07-24

R-BAND(TM) RESPIRATORY SENSOR

Applicant Buckman Co., Inc.

K number K900264

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BZQ 1990-07-17

TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC)

Applicant S & W Medico Teknik

K number K884120

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BZQ 1990-07-13

MODIFIED MODELS 9500,9550,9200,8200,HEART RATE MON

Applicant Aequitron Medical, Inc.

K number K902785

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BZQ 1990-07-13

MODEL 9200 RESPIRATION/HEART RATE MONITOR

Applicant Aequitron Medical, Inc.

K number K901656

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BZQ 1990-06-25

KNIGHTWATCH SYSTEM

Applicant Createch Corp.

K number K896934

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BZQ 1990-06-14

ARVEE APNEA MONITOR, MODEL 4800

Applicant Arvee Medical, Inc.

K number K900730

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BZQ 1990-06-08

MESAMIV RECORDER

Applicant Madaus Medtec, Inc.

K number K901466

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BZQ 1990-04-26

'APNEA-ELECTRODE'

Applicant Medical Science Products, Inc.

K number K900826

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BZQ 1990-01-22

MESAM RECORDER

Applicant Madaus Medtec, Inc.

K number K894641

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BZQ 1989-10-24

AR-800PA RESPIRATION MODULE

Applicant Nihon Kohden America, Inc.

K number K891486

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BZQ 1989-09-06

ARVEE APNEA MONITOR, MODEL 2400

Applicant Arvee Medical, Inc.

K number K891676

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BZQ 1989-03-06

RESPIRATORY AIRWAY TUBE MONITOR (RATM)

Applicant Vascucare, Inc.

K number K883158

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BZQ 1989-01-30

MODEL 9550/9500 RESPIRATION/HEART RATE MONITOR

Applicant Aequitron Medical, Inc.

K number K884637

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BZQ 1988-11-02

HEALTH-WATCH BED MONITOR

Applicant Engineering Developments, Co.

K number K882377

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BZQ 1988-09-06

SAM(TM) MODEL ONE

Applicant Sentel Tech. C/O Criticare Systems, Inc.

K number K880725

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BZQ 1988-08-05

8800 SERIES MICRO-PROCESSOR-BASED APNEA MONITORS

Applicant Atlas Researches , Ltd.

K number K862747

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BZQ 1988-06-10

MODEL 9216 RESPIRATION/HEART RATE MONITOR

Applicant Aequitron Medical, Inc.

K number K881266

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BZQ 1988-04-01

BREATHGUARD APNEA MONITOR

Applicant Lada Intl., Inc.

K number K872833

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BZQ 1988-03-21

CM 3000 THE MONITOR

Applicant Lifeline Medical Systems, Inc.

K number K874898

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BZQ 1988-02-11

HEALTHDYNE RATE METER

Applicant Healthdyne, Inc.

K number K874814

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