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 1987-11-23

MODEL 500E INFANT MONITORING SYSTEM

Applicant Ge Medical Systems Information Technologies

K number K873791

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BZQ 1987-11-23

VITALOG PMS-8 (MODIFICATION)

Applicant Vitalog Corp.

K number K871813

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BZQ 1987-10-26

INFANT MONITOR, MODEL 2400

Applicant Arvee Medical, Inc.

K number K872631

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BZQ 1987-10-09

MODEL NUMBER 9216 RESPIRATION/HEART RATE MONITOR

Applicant Aequitron Medical, Inc.

K number K872954

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BZQ 1987-07-16

ROKONICS 8500

Applicant Rokonics, Inc.

K number K871576

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BZQ 1987-06-05

MODEL NUMBER 8200 RESPIRATION/HEART RATE MONITOR

Applicant Aequitron Medical, Inc.

K number K871551

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BZQ 1987-04-20

MODEL 2000W OPTION H CONFIGURATION

Applicant Edentec Corp.

K number K871302

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BZQ 1987-03-27

ADULT APNEA MONITOR (20), MONITOR INTERFACE (30)

Applicant Applied Membrane Technology, Inc.

K number K870835

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BZQ 1987-03-27

MODEL 3500 INFANT RESPIRATION & HEART RATE MONITOR

Applicant Bio-Dyne, Inc.

K number K864261

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BZQ 1987-03-16

LIFEWATCH(R) PORTABLE MONITORING SYSTEM

Applicant Lifewatch Systems, Inc.

K number K864419

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BZQ 1987-03-09

LIFEWATCH PLUS

Applicant The Perkin-Elmer Corp.

K number K870661

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BZQ 1987-02-03

LIFESCOPE 6, OEC-6120 PORTABLE PATIENT MONITOR REC

Applicant Nihon Kohden America, Inc.

K number K862462

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BZQ 1987-01-28

LIFEWATCH SENSOR BELT

Applicant Lifewatch Systems, Inc.

K number K864487

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BZQ 1986-10-16

KONTRON VITALMON 5010 PATIENT MONITOR

Applicant Kontron Instruments, Inc.

K number K852249

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BZQ 1986-10-15

MONAGHAN RVM, MODEL 760 AND 761

Applicant Monaghan Medical Corp.

K number K863612

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BZQ 1986-09-19

APNET RESPIRATION MONITOR

Applicant Wireless Monitors, Inc.

K number K862962

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BZQ 1986-06-13

RESPISOMNOGRAPH

Applicant Dickstein, Shapiro & Morin

K number K861326

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BZQ 1986-05-30

BIOCHEM 515 RESPIRATION MONITOR

Applicant Biochem International, Inc.

K number K854333

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BZQ 1986-05-21

INFANT MONITOR

Applicant Healthdyne, Inc.

K number K861484

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BZQ 1986-05-16

DEMAND OXYGEN SAVER SYSTEM (D02S)

Applicant Applied Membrane Technology, Inc.

K number K861423

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BZQ 1986-05-14

NEO-TRAK 502 INFANT MONITOR

Applicant Ge Medical Systems Information Technologies

K number K861407

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BZQ 1986-05-09

AS165 RESPIRATION MONITOR

Applicant Air-Shields, Inc.

K number K861743

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BZQ 1986-05-01

INFAGUARD TM

Applicant Lifewatch Systems, Inc.

K number K854705

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BZQ 1986-04-18

GREENLEAF SMART POLYGRAPH PROGRAM

Applicant Greenleaf Science Corp.

K number K854355

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BZQ 1986-04-01

MODEL 9000 RECORDING SYSTEM/RESPIRATION MONITORING

Applicant Oxford Medilog, Inc.

K number K860455

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BZQ 1986-01-30

HEALTHDYNE'S EVENT RECORDER SYSTEM

Applicant Healthdyne, Inc.

K number K860254

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BZQ 1986-01-21

EMERGENT TECHNOLOGY VENTILATORY EFFORT MONITOR VEM

Applicant Emergent Technology Corp.

K number K853252

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BZQ 1986-01-21

ROKONICS SENTRY MODEL 8500

Applicant Rokonics, Inc.

K number K851819

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BZQ 1985-11-18

MONAGHAN RVM, MODEL 760 OR MODEL 761

Applicant Monaghan Medical Corp.

K number K853047

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BZQ 1985-10-23

CENTURION-II, MODEL 3103 APNEA/BRADY CARDIA TRACHY

Applicant Clinical Data, Inc.

K number K851889

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BZQ 1985-09-18

LIFELINC LEADWIRE

Applicant Tronomed, Inc.

K number K853303

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BZQ 1985-09-10

LIFE LINC PATIENT CABLE

Applicant Tronomed, Inc.

K number K853452

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BZQ 1985-08-02

MEDICON MODEL 8200 AMS(APNEA MONITOR SYSTEM)

Applicant Aequitron Medical, Inc.

K number K853084

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BZQ 1985-07-15

EDENTEC MODEL 2000W APNEA MONITOR

Applicant Edentec Corp.

K number K844327

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BZQ 1985-06-24

ACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITOR

Applicant Alternative Design Systems, Inc.

K number K852515

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BZQ 1985-06-24

COROMETRICS 500 INFANT MONITOR

Applicant Ge Medical Systems Information Technologies

K number K850504

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BZQ 1985-01-18

BIOMATT-1

Applicant Biorec Us, Inc.

K number K841392

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BZQ 1984-12-04

RESPIRATION & HEART RATE MONITOR 530

Applicant Tri-Med, Inc.

K number K843681

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BZQ 1984-11-01

SUN-ONE

Applicant Ensun Medical Products, Inc.

K number K842048

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BZQ 1984-10-10

INFANT MONITOR 16900

Applicant Healthdyne, Inc.

K number K843546

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BZQ 1984-05-30

LIFECYCLE AEROBIC MONITOR 123

Applicant Heart Rate, Inc.

K number K840488

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BZQ 1983-09-26

APNEA ALARM FOR ADULT-PEDIATRIC & NEON

Applicant Plasmedics, Inc.

K number K831601

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BZQ 1983-09-12

ANESTHESIA/RESPIRATORY DISCONNECT -

Applicant Plasmedics, Inc.

K number K831650

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BZQ 1983-01-12

EEG & RESPIRATION MODULES POLYGRAPH

Applicant Nihon Kohden America, Inc.

K number K823563

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BZQ 1982-11-04

TRIMED 510 APNEA MONITOR

Applicant Tri-Med, Inc.

K number K822819

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BZQ 1982-07-13

HEALTHDYNE MODEL 16900 INFANT MONITOR

Applicant Healthdyne, Inc.

K number K821731

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BZQ 1982-05-03

RESPIRATION MONITOR 1000

Applicant Intl. Medical Devices , Ltd.

K number K820778

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BZQ 1982-04-15

INFANT MONITOR

Applicant Healthdyne, Inc.

K number K820645

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BZQ 1982-03-26

JLS GROUP INFANT MONITOR

Applicant Jls Group, Inc.

K number K820374

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BZQ 1982-01-12

INFALERT

Applicant Briox Technologies, Inc.

K number K813507

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BZQ 1981-11-16

MEDICON #8200 AMS

Applicant Medicon, Inc.

K number K812873

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BZQ 1981-10-23

MEDDARS/ULTRA IMAGER RESPIRATION MODULE

Applicant Honeywell, Inc.

K number K812667

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BZQ 1981-09-24

INFANT APNEA MONITOR MODEL 100

Applicant Medix Medical Electronics (U.S.A.), Inc.

K number K812045

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BZQ 1981-08-04

RESPIRATION RATE MONITOR 120/121

Applicant Medix Medical Electronics (U.S.A.), Inc.

K number K812044

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BZQ 1981-07-31

VMA PEDIATRIC APNEA MATTRESS

Applicant Vickers America Medical Corp.

K number K811865

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BZQ 1981-07-31

OECO APNEA MONITOR

Applicant Oeco

K number K811628

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BZQ 1981-06-02

RESPIRATORY SENSOR (MODEL 409 W/NASOPH.)

Applicant Impact Instrumentation, Inc.

K number K811265

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BZQ 1981-06-02

RESPIRATORY SENSOR

Applicant Impact Instrumentation, Inc.

K number K811014

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BZQ 1981-03-20

NEO NATAL RESPIRATION FUNCTION BLOCK

Applicant Honeywell, Inc.

K number K810175

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BZQ 1981-03-17

RESPIRATION FUNCTION BLOCKS

Applicant Honeywell, Inc.

K number K810174

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BZQ 1980-10-03

ECG/RESPIRATION STIMULATOR

Applicant Healthdyne, Inc.

K number K802205

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BZQ 1980-09-16

PDS MODEL 3000 ADULT RESPIRATION MODULE

Applicant General Electric Co.

K number K802046

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BZQ 1980-08-27

RESPONDER II

Applicant Clinical Microsystems Intl.

K number K801894

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BZQ 1980-02-21

RESPIRATION/APNEA AMPLIFIER MODEL 3105

Applicant Electronics For Medicine, Inc.

K number K792528

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BZQ 1979-02-27

PREAMPLIFIER MODULE, EKG RESPIRATION

Applicant Abbott Medical Electronics Co.

K number K790304

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BZQ 1979-01-10

MONITOR HS7

Applicant Scientific & General Pty. , Ltd.

K number K782045

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BZQ 1979-01-10

MONITOR HS8

Applicant Scientific & General Pty. , Ltd.

K number K782044

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BZQ 1978-12-18

ALARM UNIT, BATTERY OPERATED

Applicant Thompson Respiration Products, Inc.

K number K781158

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BZQ 1978-10-02

MODEL LS-80 ADULT VENTILATION MONITOR

Applicant Bourns Medical Systems, Inc.

K number K781515

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BZQ 1977-08-04

LUNG VOLUME & PRESSURE MONITOR

Applicant Research Development Corp.

K number K771407

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BZQ 1977-06-14

LUNG-MECHANICS MONITOR

Applicant Research Development Corp.

K number K771019

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BZQ 1977-03-07

GOWN, SURGICAL, SURGINE

Applicant Surgikos, Inc.

K number K770250

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BZQ 1976-10-28

MONITOR, RESPIRATORY (CPAP)

Applicant Sherwood Medical Industries

K number K760339

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BZQ 1976-08-11

RESPIRATORY SUPPORT SYSTEM, NEONATAL

Applicant Sherwood Medical Industries

K number K760340

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