Calculator, Predicted Values, Pulmonary Function

FDA product code BTY · 64 cleared devices

Class 2 Anesthesiology

Regulation: 21 CFR 868.1890
Review panel: AN
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1978-05-16 – 2026-08-20

BTY 2026-08-20

CPETWise Platform

Applicant Medibyt , Ltd.

K number K260242

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BTY 2024-10-17

Ascent Cardiorespiratory Diagnostic Software

Applicant Medical Graphics Corporation

K number K242809

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BTY 2024-05-28

SpiroSphere, SpiroSphereECG, CardioSphere

Applicant Eresearchtechnology GmbH

K number K223629

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BTY 2024-02-21

Pulmonary Function Tester, Model: A9

Applicant Guangzhou Homesun Medical Technology Co., Ltd.

K number K231561

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BTY 2023-06-23

Virtus Metabolic Monitor

Applicant Virtus Technology Aps

K number K222982

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BTY 2022-07-15

Model 9100 PFT/DICO

Applicant Vitalograph Ireland, Ltd.

K number K221030

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BTY 2021-01-28

MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU

Applicant Eresearchtechnology GmbH

K number K202754

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BTY 2020-02-06

Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors

Applicant Cosmed Srl

K number K190800

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BTY 2019-04-12

Ascent Cardiorespiratory Diagnostic Software

Applicant Medical Graphics Corporation

K number K181912

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BTY 2019-02-15

SpiroSphere

Applicant Eresearchtechnology GmbH

K number K173937

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BTY 2017-02-22

EasyOne Pro Respiratory Analysis System

Applicant Ndd Medizintechnik AG

K number K161534

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BTY 2016-01-21

Shape-HF Cardiopulmonary Testing System

Applicant Shape Medical Systems, Inc.

K number K150888

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BTY 2012-11-19

SENTRYSUITE PRODUCT LINE

Applicant Carefusion Germany 234 GmbH

K number K122699

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BTY 2012-09-27

EASYONE PRO RESPIRATORY TESTING DEVICE

Applicant Ndd Medizitechnik AG

K number K120635

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BTY 2012-05-10

SENTRYSUITE PRODUCT LINE

Applicant Carefusion Germany 234 GmbH

K number K113813

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BTY 2011-08-12

SENTRYSUITE PRODUCT LINE

Applicant Carefusion Germany 234 GmbH

K number K111053

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BTY 2010-01-27

EASYONE PRO RESPIRATORY ANALYSIS SYSTEM

Applicant Ndd Medizitechnik AG

K number K091428

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BTY 2009-03-31

SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM

Applicant Shape Medical Systems, Inc.

K number K090722

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BTY 2008-12-02

MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT

Applicant Cardinal Health Germany 234 GmbH

K number K082539

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BTY 2008-08-20

VIP PULMONARY FUNCTION SYSTEM

Applicant Viasys Healthcare GmbH

K number K080510

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BTY 2008-06-26

FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT

Applicant Viasys Healthcare GmbH

K number K080734

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BTY 2007-08-14

MASTERSCREEN PNEUMO & MASTERSCOPE

Applicant Viasys Healthcare GmbH

K number K071753

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BTY 2007-05-11

MODIFICATION TO FLOWSCREEN

Applicant Viasys Healthcare GmbH

K number K062011

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BTY 2004-09-28

COSMED PONY FX

Applicant Cosmed Srl

K number K040549

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BTY 2003-07-30

SPIROSOFT

Applicant Viasys Healthcare GmbH

K number K031194

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BTY 2003-01-02

COSMED MICROQUARK

Applicant Cosmed Srl

K number K020745

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BTY 2000-12-14

METALYZER, MODEL 2; METALYZER, MODEL 3

Applicant Cortex Biophysik GmbH

K number K993641

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BTY 2000-03-29

SPIRO PRO

Applicant Erich Jaeger GmbH

K number K000648

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BTY 1998-10-30

STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIES

Applicant Sensor Medics Corp.

K number K981366

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BTY 1998-07-28

MODIFICATION TO THE OXYCONALPHA

Applicant Erich Jaeger B.V.

K number K980094

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BTY 1997-02-14

DSXL DIFFUSION SPIROMETER

Applicant Inair , Ltd.

K number K961252

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BTY 1995-03-20

OXYCON-ALPHA

Applicant Mijnhardt B.V.

K number K942230

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BTY 1994-11-22

VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS

Applicant Sensor Medics Corp.

K number K942211

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BTY 1994-03-07

MASTER SCREEN PNUEMO

Applicant Erich Jaeger, Inc.

K number K933839

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BTY 1994-03-07

FLOWSCREEN

Applicant Erich Jaeger, Inc.

K number K932744

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BTY 1994-02-10

UPGRADED SPIROMETER ST-90

Applicant Futuremed Div. of Future Impex Corp.

K number K933511

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BTY 1993-12-17

PFM PROFESSIONAL 7000 SPIROMETER

Applicant Advanced Medical Systems, Inc.

K number K932278

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BTY 1993-12-17

MODEL 508 PATIENT MONITOR

Applicant Criticare Systems, Inc.

K number K921309

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BTY 1993-07-26

VITALOGRAPH DATA STORAGE SPIROMETER

Applicant Vitalograph , Ltd.

K number K930085

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BTY 1991-07-22

CMD/DLCO DIAGNOSTIC SPIROMETER

Applicant Spirometrics, Inc.

K number K911358

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BTY 1989-10-27

EBS2605 INFANT HUGGER

Applicant Equilibrated Bio Systems, Inc.

K number K892705

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BTY 1989-10-19

MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP

Applicant Pneumedics, Inc.

K number K894667

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BTY 1988-09-29

PULMONARY FORCED FLOW SYSTEM (PUFFS)

Applicant Medical Associated Services, Inc.

K number K883008

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BTY 1988-06-10

UPDATED MANUAL FOR PEDS - PULMONARY EVAL. & DIAG.

Applicant Medical Associated Services, Inc.

K number K881122

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BTY 1987-03-06

L.A.P. SPIROMETER

Applicant Timeter Instrument Corp.

K number K864836

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BTY 1986-11-07

PEDS PULMONARY EVALUATION & DIAGNOSTIC SYSTEM

Applicant Medical Associated Services, Inc.

K number K864087

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BTY 1986-10-27

SPIROLOOP-PULMONARY EXERCISE SYSTEM

Applicant Pneumedics, Inc.

K number K863087

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BTY 1986-06-23

ST-90 SPIRO ANALIZER

Applicant Future Impex Corp.

K number K861487

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BTY 1986-05-19

SPIROMETRY MODULE

Applicant Medical Graphics Corp.

K number K861486

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BTY 1986-02-05

SPIROMETER, MODEL TS-500 PART #SLZ7534

Applicant Teledyne Avionics Div. of Teledyne

K number K855068

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BTY 1986-01-30

SPIROMETER TS-400 SLZ 7547

Applicant Teledyne Avionics Div. of Teledyne

K number K855069

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BTY 1986-01-10

CUSTO VIT PULMONARY FUNCTION ANALYSIS SYSTEM

Applicant Versacor, Inc.

K number K854745

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BTY 1985-11-29

ELF

Applicant Cardio-Respiratory

K number K853433

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BTY 1985-02-14

SPIROMETRICS 2453 & SMI III

Applicant Spirometrics, Inc.

K number K850045

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BTY 1983-01-28

SPIROTECH 300

Applicant Spirotech, Inc.

K number K823771

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BTY 1983-01-21

VITALOGRAPH PFT PRINTER

Applicant Vitalograph , Ltd.

K number K823683

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BTY 1982-07-26

INFORMED REMOTE FIELD UNIT MODEL IFM1000

Applicant Burditt & Calkins-Siemens-Elema

K number K821712

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BTY 1981-12-03

PTT-200 PULMONARY RECEIVER/MICROPROCES

Applicant Pharmaquest Corp.

K number K812850

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BTY 1981-12-03

PTT-200 TELEPHONIC PULMONARY TRANSMITT

Applicant Pharmaquest Corp.

K number K812849

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BTY 1981-11-27

PFT SCREENER (SYSTEM 1100)

Applicant Medical Graphics Corp.

K number K812792

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BTY 1981-03-24

ELECTRONIC SPIROMETER MODEL MFR-8100

Applicant Nihon Kohden America, Inc.

K number K810712

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BTY 1980-12-22

APEXLINE OF PULMONARY FUNCT. INSTRUM.

Applicant Warren E. Collins, Inc.

K number K803053

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BTY 1979-04-04

MEDISTOR II

Applicant Cybermedic, Inc.

K number K790579

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BTY 1978-05-16

PULMONARY FUNCTION TESTER

Applicant Warren E. Collins, Inc.

K number K780584

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