Calculator, Pulmonary Function Data

FDA product code BZC · 87 cleared devices

Class 2 Anesthesiology

Regulation: 21 CFR 868.1880
Review panel: AN
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-04-05 – 2024-09-17

BZC 2024-09-17

STS

Applicant Techbopulm, Ltd.

K number K240293

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BZC 2019-08-23

Vyntus/SentrySuite Product Line

Applicant Vyaire Medical

K number K183567

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BZC 2019-08-16

Vyntus BODY

Applicant Vyaire Medical, Inc.

K number K190853

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BZC 2018-11-30

Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART

Applicant Vyaire Medical, Inc.

K number K181524

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BZC 2017-06-20

COSMED K5 Wearable Metabolic Technology

Applicant Cosmed Srl

K number K162515

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BZC 2016-10-21

MiniBox +

Applicant Pulmone Advanced Medical Devices, Ltd.

K number K161295

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BZC 2011-11-01

LCI OPTION FOR INNOCOR

Applicant Innovision A/S

K number K102047

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BZC 2007-10-10

MASTERSCREEN & OXYCON CPX

Applicant Viasys Healthcare GmbH

K number K072323

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BZC 2005-12-22

ZAN LUNG-FUNCTION LAB

Applicant Zan Messgerate GmbH

K number K052328

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BZC 2004-04-07

MASTERSCREEN CPX AND OXYCON CPX

Applicant Viasys Healthcare GmbH

K number K040698

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BZC 2003-11-12

OXYCON MOBILE

Applicant Erich Jaeger GmbH

K number K023120

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BZC 2002-05-17

INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400

Applicant Collins Medical, Inc.

K number K011344

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BZC 2001-02-22

CORTEX METAMAX

Applicant Cortex Biophysik GmbH

K number K001631

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BZC 2001-01-11

COSMED QUARK

Applicant Cosmed Srl

K number K001174

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BZC 2000-07-12

AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO

Applicant Erich Jaeger GmbH

K number K001502

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BZC 2000-02-22

OXYCON PRO

Applicant Erich Jaeger B.V.

K number K992214

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BZC 1998-10-16

COSMO PLUS WITH NICO, MODEL 8200

Applicant Novametrix Medical Systems, Inc.

K number K982499

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BZC 1998-10-14

CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MONITOR METEOR 100, CPT, INC. METEOR HAND HELD RESPIRATORY MECHANICS MO

Applicant Cardiopulmonary Technologies, Inc.

K number K982487

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BZC 1997-11-26

INTELLIFLOW RESPIRATORY ANALYZER

Applicant Simtec, Inc.

K number K970840

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BZC 1997-09-10

COSMED K4

Applicant Cosmed Srl

K number K963373

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BZC 1997-04-04

VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101

Applicant Novametrix Medical Systems, Inc.

K number K964360

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BZC 1997-04-01

BENCHMARK TRANSFER TEST

Applicant P.K. Morgan , Ltd.

K number K954730

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BZC 1997-03-06

THE PORTABLE FAMILY - MEDI-FACTS DX1 PORTABLE LITE AND DX1 PORTABLE PLUS

Applicant Creative Biomedics, Inc.

K number K964939

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BZC 1997-01-22

CO 2 SMO PLUS

Applicant Novametrix Medical Systems, Inc.

K number K963380

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BZC 1997-01-09

AUTOLINK BODY PLETHYSMOGRAPH

Applicant P.K. Morgan , Ltd.

K number K960121

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BZC 1996-12-09

TRANSFLOW TEST

Applicant P.K. Morgan , Ltd.

K number K953990

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BZC 1996-05-29

VENTRAK RMMS 1550

Applicant Novametrix Medical Systems, Inc.

K number K960831

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BZC 1996-04-23

ACKRAD ESOPHAGEAL BALLOON CATHETER SET

Applicant Ackrad Laboratories

K number K952542

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BZC 1995-09-15

DIRECTIONAL CONTROL VALVES INFLATABLE BALLOON-TYPE AND CONTROLLERS

Applicant Hans Rudolph, Inc.

K number K946077

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BZC 1995-08-11

DX1-PORTABLE

Applicant Creative Biomedics, Inc.

K number K951157

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BZC 1995-06-16

MMS-2400

Applicant Parvo Medics, Inc.

K number K941843

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BZC 1995-05-25

TEEN 100

Applicant Aerosport, Inc.

K number K945213

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BZC 1995-03-03

LUNG DIFFUSION

Applicant Nordan Smith Welding Supplies

K number K942864

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BZC 1994-09-27

LUNG DIFFUSION

Applicant Acetylene Gas Co.

K number K935309

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BZC 1993-06-25

ARGIS PULMONARY FUNCTION TESTING SYSTEM

Applicant Med Science

K number K921306

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BZC 1992-12-02

SENSORMEDICS MODEL 2600 PEDIATRIC PULMOONARY CART

Applicant Sensor Medics Corp.

K number K915833

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BZC 1992-12-01

MODEL 2900 METABOLIC MEASUREMENT CART

Applicant Sensor Medics Corp.

K number K915686

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BZC 1992-07-02

MULTISPIRO-BREEZE

Applicant Multispiro, Inc.

K number K913681

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BZC 1991-05-06

SPIROSCOPE

Applicant Grandcor Medical Systems

K number K905480

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BZC 1990-11-29

BIORE CP-100 CARDIOPULMONARY MONITOR

Applicant Bicore Monitoring Systems

K number K900696

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BZC 1990-03-16

MODIFIED STAR CALC

Applicant Infrasonics Corp.

K number K895963

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BZC 1989-10-27

PEDS WATER FILLED CATHETER/TRANSDUCER SYSTEM

Applicant Medical Associated Services, Inc.

K number K893845

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BZC 1989-10-24

OS-1 OCCLUSION SYSTEM - 1

Applicant Medical, Inc.

K number K894839

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BZC 1989-09-22

PHYSIO-DYNE EASI (EASY ANALOG SAMPLING INTERFACE)

Applicant Physio-Dyne Instrument Corp.

K number K892670

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BZC 1989-06-16

SPIRO-LINK REAL TIME SPIROMETRY SYSTEM

Applicant Biocom Intl., Inc.

K number K892121

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BZC 1989-03-31

Q-PLEX 1

Applicant Quinton, Inc.

K number K881235

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BZC 1989-03-09

ARGIS PULMONARY FUNCTION TESTING SYSTEM

Applicant Advanced Signal Processing, Inc.

K number K883732

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BZC 1988-08-16

STAR CALC

Applicant Infrasonics Corp.

K number K875027

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BZC 1986-05-09

SPINNAKER

Applicant Cybermedic, Inc.

K number K861418

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BZC 1986-04-02

VISTA INTERFACE SYSSTEM

Applicant Vacumetrics, Inc.

K number K860844

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BZC 1986-02-28

COMPUMED PULMONARY FUNCTION ANALYZER MODEL 307B

Applicant Compumed, Inc.

K number K854626

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BZC 1986-02-21

ALVEO-DIFFUSION TEST

Applicant Erich Jaeger, Inc.

K number K853443

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BZC 1986-01-30

SPIROMETER MODEL TS-200 SLZ 7541

Applicant Teledyne Avionics Div. of Teledyne

K number K855070

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BZC 1985-11-14

MVP - 6000

Applicant Waters Instruments, Inc.

K number K852909

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BZC 1985-07-08

LPA-3 PRINTER

Applicant Life Products, Inc.

K number K851805

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BZC 1984-12-27

OXYSCREEN

Applicant Erich Jaeger, Inc.

K number K843860

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BZC 1984-11-01

APTA-BRONCHOSCREEN

Applicant Erich Jaeger, Inc.

K number K843852

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BZC 1984-11-01

AW TEST

Applicant Erich Jaeger, Inc.

K number K843848

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BZC 1984-10-16

PNEUMOSCREEN

Applicant Erich Jaeger, Inc.

K number K843849

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BZC 1984-07-26

LUNG ANALYZER CM-310

Applicant Cybermedic, Inc.

K number K842760

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BZC 1984-04-02

PULMONARY FUNCTION SYS-3000

Applicant Med-Science Electronics, Inc.

K number K840711

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BZC 1983-08-31

RS-RESIDUAL VOLUME SYSTEM

Applicant Warren E. Collins, Inc.

K number K831778

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BZC 1983-08-31

COLLINS DS

Applicant Warren E. Collins, Inc.

K number K831777

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BZC 1983-08-26

COLLINS EAGLE II

Applicant Warren E. Collins, Inc.

K number K831779

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BZC 1983-06-10

ACOH WELLNESS TESTER

Applicant Bradley, Campbell & Carney

K number K830954

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BZC 1982-11-16

PULMONARY FUNCTION LAB SYSTEM 1070

Applicant Medical Graphics Corp.

K number K822986

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BZC 1981-08-20

OSCILLAIRE

Applicant Jones Medical Instrument Co.

K number K812001

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BZC 1981-04-10

PDS CARDIAC CALC. SOFTW. PROGR. #A3604AF

Applicant General Electric Co.

K number K810751

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BZC 1981-02-23

INSPIRON PULMONARY FUNCTION ANALYZER

Applicant C.R. Bard, Inc.

K number K802920

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BZC 1981-02-12

SYSTEM 86 COMPUTERIZED LUNG VOL. SPIROME

Applicant Cardio Pulmonary Instruments

K number K810243

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BZC 1981-02-05

SYSTEM 84 COMPUTERIZED LUNG VOL. SPIROM

Applicant Cardio Pulmonary Instruments

K number K810196

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BZC 1981-01-28

AUTOMATED PULMONARY FUNCTION LABORATORY

Applicant Cardio Pulmonary Instruments

K number K803255

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BZC 1980-12-17

SPIROMETRIC COMPUTER #SC-10

Applicant Cavitron Corp.

K number K802928

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BZC 1980-10-03

ANESTHESIA GAS MACHINE

Applicant Puritan Bennett Corp.

K number K802116

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BZC 1980-10-03

SYSTEM 80 COMPUTERIZED SPIROMETER

Applicant Pulmonary Testing Systems

K number K801920

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BZC 1980-10-03

SYSTEM 88 COMPUTERIZED DIFFUSION ANALY

Applicant Pulmonary Testing Systems

K number K801919

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BZC 1980-10-03

SYSTEM 82 COMPUTERIZED LUNG VO. SPIRO

Applicant Pulmonary Testing Systems

K number K801918

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BZC 1980-10-03

INFANT VENTILATORY MEASUREMENT SYSTEM

Applicant Medical Graphics Corp.

K number K801497

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BZC 1980-08-04

PFT CALIBRATOR

Applicant Spital Medical, Inc.

K number K801597

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BZC 1980-07-21

SURVEYOR I, RESPIRATORY COMPUTER SYSTEM

Applicant The Devilbiss Co.

K number K801526

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BZC 1980-06-17

F.R.C. APPARATUS

Applicant Hogan/Cologne Ent.

K number K801088

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BZC 1980-03-25

MEDISTOR III LUNG ANALYZER

Applicant Cybermedic, Inc.

K number K800547

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BZC 1979-08-16

VITALOGRAPH FUNCTION ANALYZER

Applicant Vitalograph , Ltd.

K number K791503

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BZC 1979-02-16

MODEL V 4207 INTEGRATING PLUG-IN

Applicant Electronics For Medicine, Inc.

K number K790185

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BZC 1978-03-14

PULMONARY FUNCTION TESTER, COMPUTERIZED

Applicant Warren E. Collins, Inc.

K number K780328

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BZC 1978-03-14

ANALYZER, PULMONARY FUNCTION

Applicant Hospal Medical Corp.

K number K780322

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BZC 1977-04-05

PC-30 PULMONARY COMPUTER

Applicant Cavitron Corp.

K number K770532

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