Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

FDA product code DRT · 339 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.2300
Review panel: CV
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-07-19 – 2026-09-25

DRT 2026-09-25

DistaSense(TM) (v1)

Applicant Life Detection Technologies

K number K254058

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DRT 2026-05-20

The Circadia C300 System (C300)

Applicant Circadia Health, Inc.

K number K261286

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DRT 2026-02-03

The Circadia C300 System (C300)

Applicant Circadia Health, Inc.

K number K252676

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DRT 2026-01-28

Sleepiz One+ (Model 2.5)

Applicant Sleepiz AG

K number K253388

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DRT 2025-07-29

Sleepiz One+ (2.5)

Applicant Sleepiz AG

K number K251364

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DRT 2024-05-30

The Circadia C200 System

Applicant Circadia Technologies, Ltd.

K number K234003

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DRT 2024-03-22

Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software

Applicant Murata Vios, Inc.

K number K232354

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DRT 2024-02-09

Neteera 130H-Plus Vital Sign Monitoring Sensor

Applicant Neteera Technologies , Ltd.

K number K231733

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DRT 2023-08-18

Sleepiz One+

Applicant Sleepiz AG

K number K223163

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DRT 2022-09-28

Neteera 130H/131H Vital Sign Monitoring Sensor

Applicant Neteera Technologies , Ltd.

K number K212143

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DRT 2021-05-14

Cardiac Trigger Monitor

Applicant Ivy Biomedical Systems, Inc.

K number K202138

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DRT 2021-04-26

Vital Sign Monitoring Sensor (Model :XK300)

Applicant Xandar Kardian, Inc.

K number K202464

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DRT 2019-03-07

Philips wearable biosensor-G5 Solution

Applicant Connected Sensing- A Division of Philips Medical Systems

K number K181165

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DRT 2018-06-22

Vios Monitoring System™ Model 2050

Applicant Vios Medical, Inc.

K number K172586

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DRT 2017-05-17

Cardiac Trigger Monitor

Applicant Ivy Biomedical Systems, Inc.

K number K170828

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DRT 2016-05-27

Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor

Applicant Ivy Biomedical Systems, Inc.

K number K151781

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DRT 2013-01-25

ESA615

Applicant Fluke Biomedical

K number K121860

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DRT 2012-10-11

ESA620 ELECTRICAL SAFETY ANALYZER

Applicant Fluke Biomedical

K number K121722

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DRT 2011-09-02

PROSIM 4, PROSIM 6, PROSIM 8

Applicant Fluke Biomedical

K number K110429

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DRT 2011-07-22

CARDIAC TRIGGER MONITOR

Applicant Ivy Biomedical Systems, Inc.

K number K110987

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DRT 2011-04-13

MPS450 MULTIPARAMETER SIMULATOR

Applicant Fluke Biomedical

K number K103336

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DRT 2010-10-19

HRV ACQUIRE

Applicant Wr Medical Electronics Co.

K number K092809

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DRT 2010-09-15

ZOLL PROPAQ M

Applicant Zoll Medical Corporation, World Wide Headquarters

K number K102174

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DRT 2010-04-15

LIFEBED NETWORK PATIENT VIGILANCE SYSTEM

Applicant Hoana Medical, Inc.

K number K100745

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DRT 2009-10-02

LIFEGURNEY NETWORK PATIENT VIGILANCE SYSTEM

Applicant Hoana Medical, Inc.

K number K092037

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DRT 2009-07-24

UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE

Applicant Ivy Biomedical Systems, Inc.

K number K091985

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DRT 2009-05-27

506CN PATIENT MONITOR

Applicant Criticare Systems, Inc.

K number K091050

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DRT 2009-04-13

LIFEBED NETWORK PATIENT VIGILANCE SYSTEM

Applicant Hoana Medical, Inc.

K number K083534

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DRT 2009-02-13

CARDIAC TRIGGER, MODEL: CTM300

Applicant Ivy Biomedical Systems, Inc.

K number K083854

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DRT 2009-01-16

PAM 3000

Applicant Wireless 2000 RF & Uwb Technologies , Ltd.

K number K082626

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DRT 2008-09-26

LIFEBED PATIENT VIGILANCE SYSTEM

Applicant Hoana Medical, Inc.

K number K082366

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DRT 2007-09-19

PRESYM TRCG TRACHEOCARDIOGRAM, MODEL 112

Applicant Presym, Inc.

K number K063735

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DRT 2006-08-04

12 RL ALGORITHM

Applicant Ge Medical Systems Information Technologies

K number K060307

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DRT 2006-02-02

LG1 INTELLIGENT MEDICAL VIGILANCE SYSTEM

Applicant Hoana Medical, Inc.

K number K052446

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DRT 2005-08-12

506 PATIENT MONITOR

Applicant Ciriticare Systems, Inc.

K number K051038

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DRT 2005-03-01

TRIFIT 700

Applicant Healthfirst Corp.

K number K033646

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DRT 2005-02-03

TRANSMITTER, ZS-940PA SERIES

Applicant Nihon Kohden America, Inc.

K number K043517

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DRT 2005-01-10

MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701

Applicant Invivo Research, Inc.

K number K043354

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DRT 2004-03-03

PM-8000 PATIENT MONITOR, MODEL 8000

Applicant Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

K number K032733

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DRT 2003-04-08

ENVAN HEART RATE MONITOR

Applicant Envan, LLC

K number K030656

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DRT 2002-11-04

PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES)

Applicant Ivy Biomedical Systems, Inc.

K number K023616

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DRT 2002-08-14

507EL VITAL SIGNS MONITOR

Applicant Criticare Systems, Inc.

K number K022435

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DRT 2002-07-23

MICROPAQ, MODELS 402, 404

Applicant Welch Allyn Protocol, Inc.

K number K021681

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DRT 2002-02-15

SIEMENS INFINITY SC 6002XL MODIFICATIONS

Applicant Siemens Medical Solutions USA, Inc.

K number K020144

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DRT 2001-11-15

SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM

Applicant Cobe Cardiovascular, Inc.

K number K012763

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DRT 2001-08-20

PROPAQ ENCORE MODELS 202, 204, 206; PROPAQ CS MODELS 242, 244, 246

Applicant Welch Allyn Protocol, Inc.

K number K012451

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DRT 2001-05-16

ACTIVEECG

Applicant Active Corp.

K number K010587

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DRT 2001-01-19

A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR

Applicant A&D Engineering, Inc.

K number K002061

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DRT 2001-01-12

ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM

Applicant Zoe Medical, Inc.

K number K001775

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DRT 2000-11-21

MICROPAQ, MODELS 402 AND 404

Applicant Protocol Systems, Inc.

K number K002725

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DRT 1999-08-19

ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR

Applicant Medical Data Electronics

K number K992413

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DRT 1999-08-18

ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR

Applicant Medical Data Electronics

K number K992411

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DRT 1999-07-08

ATLAS MONITOR

Applicant Welch Allyn, Inc.

K number K984033

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DRT 1998-11-03

DATEX-ENGSTROM LIGHT MONITOR MODELS F-LM1, F-LMP1

Applicant Datex-Engstrom, Inc.

K number K981378

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DRT 1998-10-28

MILLENNIA 3500 SERIES MONITOR WITH ANTHESTHETIC AGENT

Applicant Invivo Research, Inc.

K number K974581

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DRT 1998-06-26

PASSPORT 5L-CE MODEL 0998-00-0131XXX

Applicant Datascope Corp.

K number K974178

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DRT 1998-01-13

NIHON KOHDEN BSM-1101 AND BSM-1102 PATIENT MONITOR AND ACCESSORIES

Applicant Nihon Kohden America, Inc.

K number K973918

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DRT 1997-12-09

HEART PROTECTOR (VER 1996)

Applicant N.P.N.T., Inc.

K number K965158

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DRT 1997-10-17

ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL600-0016

Applicant Alexander Mfg. Co.

K number K972789

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DRT 1997-10-17

ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M850-P

Applicant Alexander Mfg. Co.

K number K972787

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DRT 1997-02-28

MOBILE MEDICAL MONITOR (M3(A))

Applicant Scientific Applications

K number K963576

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DRT 1996-10-17

LOG-A-RYTHM MODEL 100 AND MODEL 1001

Applicant Nian-Crae, Inc.

K number K952790

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DRT 1996-08-07

CARDIO-CARD HOLTER ECG MANAGEMENT SYSTEM

Applicant Nasiff Assoc., Inc.

K number K960544

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DRT 1996-04-18

OMIN-TRAK MODEL 3500 SERIES PATIENT MONITORING SYSTEM

Applicant Safety Tek Corp.

K number K950688

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DRT 1995-10-19

EAGLE 3000 PATIENT MONITOR

Applicant Marquette Electronics, Inc.

K number K952474

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DRT 1995-09-20

RESPIRATORY AND CARDIAC SPECTRAL FREQUENCY SIGNAL PROCESSOR

Applicant Ansar

K number K941252

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DRT 1995-05-12

ECG MONITOR

Applicant Fukuda Denshi USA, Inc.

K number K944262

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DRT 1995-05-10

PROPAQ 200 MONITOR

Applicant Protocol Systems, Inc.

K number K945071

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DRT 1995-04-12

MERCURY

Applicant Mennen Medical, Inc.

K number K940081

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DRT 1995-03-10

PULSE HEART RATE MONITOR

Applicant Sensor Dynamics, Inc.

K number K943243

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DRT 1995-03-10

PRO-SPORT HEART RATE MONITOR

Applicant Sensor Dynamics, Inc.

K number K943242

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DRT 1994-11-01

K3 SYSTEM

Applicant Astro-Med, Inc.

K number K934644

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DRT 1994-10-17

PAM CARDIAC MONITOR

Applicant Technology Transfer, Inc.

K number K934684

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DRT 1994-09-21

LIONHEART 3 MULTI-PARAMETER SIMULATOR

Applicant Bio-Tek Instruments, Inc.

K number K944257

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DRT 1994-07-06

OMNI-CENTRAL STATION MONITOR

Applicant Invivo Research, Inc.

K number K936051

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DRT 1994-05-04

520 DISPLAY DRIVER- STATUS I

Applicant Vidco, Inc.

K number K926298

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DRT 1994-01-18

MEDSIM 300 PATIENT SIMULATOR

Applicant Dynatech/Nevada, Inc.

K number K935817

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DRT 1993-06-23

ESCORT 100/300 SERIES B PATIENT MONITORS

Applicant Medical Data Electronics

K number K930004

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DRT 1993-02-05

SYSTEM ATHENA, MODIFICATION

Applicant S & W Medico Teknik

K number K911611

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DRT 1992-11-09

HEWLETT-PACKARD CARDIAC CATHETERIZATION RECORDING

Applicant Hewlett-Packard Co.

K number K921194

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DRT 1992-03-27

MODIFIED BIOLOG

Applicant Micromedical Industries, Ltd.

K number K915624

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DRT 1992-03-09

GYMMAN

Applicant Lumiscope Co., Inc.

K number K920099

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DRT 1991-12-31

MODEL 556 MONITOR W/24-HR. TREND RECALL/MODIFIED

Applicant Ge Medical Systems Information Technologies

K number K910665

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DRT 1991-12-30

KELLER CARDIAC MONITOR MEDIL KMS870

Applicant Keller Medical Specialties Products, Inc.

K number K914576

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DRT 1991-12-05

SYSTEM ATHENA - PRODUCT ENHANCEMENTS

Applicant S & W Medico Teknik

K number K912049

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DRT 1991-10-15

DATASCOPE PASSPORT MONITOR

Applicant Datascope Corp.

K number K911598

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DRT 1991-10-09

TRU-VIEW MULTI-CHANNEL DISPLAY

Applicant General Devices

K number K912008

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DRT 1991-08-29

EDENTEC MODEL 3711 DIGITAL RECORDER

Applicant Edentec Corp.

K number K910870

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DRT 1991-07-30

507 NON-INVASIVE VITAL SIGNS MONITOR

Applicant Criticare Systems, Inc.

K number K910852

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DRT 1991-07-18

FUTURECARE CARELYNK IV SYSTEM

Applicant Futurecare Systems, Inc.

K number K903512

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DRT 1991-07-17

VITALMAX 2100/2200

Applicant Pace Tech, Inc.

K number K905274

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DRT 1991-07-10

HORIZON XL

Applicant Mennen Medical, Inc.

K number K911616

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DRT 1991-06-11

HEWLETT-PACKARD MODELS M1400A, M1402A & M1401A

Applicant Hewlett-Packard Co.

K number K911139

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DRT 1991-05-08

PROPAQ 102EL, 104EL AND 106EL

Applicant Protocol Systems, Inc.

K number K910882

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DRT 1991-02-07

WEP-8430A TELEMETRY CENTRAL STATION

Applicant Nihon Kohden America, Inc.

K number K904696

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DRT 1990-12-20

CARDIOMATIC MODEL MSC-2001

Applicant Medical Systems Corp.

K number K904353

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DRT 1990-08-23

MORTARA INSTRUMENT MODEL ELI 50

Applicant Mortara Instrument, Inc.

K number K902652

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DRT 1990-07-18

VITALMAX 800 NON-INVASIVE VITAL SIGN MONITOR/PULSE

Applicant Pace Tech, Inc.

K number K900451

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DRT 1990-07-13

CARDIOMATIC MODEL MSC-1001

Applicant Medical Systems Corp.

K number K902608

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DRT 1990-05-17

PCI MODEL 2041-PC TELEMETRY MONITOR

Applicant Accucore, Inc.

K number K901031

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