Spirometer, Diagnostic

FDA product code BZG · 218 cleared devices

Class 2 Anesthesiology

Regulation: 21 CFR 868.1840
Review panel: AN
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-05-26 – 2026-03-02

BZG 2026-03-02

MESI mTABLET SPIRO

Applicant Mesi D.O.O.

K number K251777

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BZG 2024-11-20

TD-7301 Spirometer (TD-7301)

Applicant Gostar Co., Ltd.

K number K241843

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BZG 2024-01-18

Air Next (NVD-02)

Applicant Nuvoair AB

K number K231416

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BZG 2023-12-15

Spirobank Oxi

Applicant Mir Medical International Research USA

K number K230501

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BZG 2023-10-19

EasyOne Sky Spirometer

Applicant Ndd Medizintechnik AG

K number K230178

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BZG 2023-08-28

Alveoair Digital Spirometer

Applicant Roundworks Technologies Private Limited

K number K222525

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BZG 2023-08-09

Air Smart Extra Spirometer

Applicant Feellife Health, Inc.

K number K222443

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BZG 2023-06-12

SpiroHome Personal, SpiroHome Clinic

Applicant Inofab Saglik Teknolojileri A.S

K number K213754

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BZG 2022-07-15

ComPAS2

Applicant Morgan Scientific, Inc.

K number K213872

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BZG 2022-01-26

Vitalograph Model 6000 Alpha

Applicant Vitalograph Ireland, Ltd.

K number K212938

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BZG 2021-06-10

Spirometer

Applicant Mehow Innovative, Ltd.

K number K201493

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BZG 2020-12-04

GoSpiro

Applicant Monitored Therapeutics, Inc.

K number K202837

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BZG 2020-10-14

Spirotrac

Applicant Vitalograph Ireland, Ltd.

K number K201562

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BZG 2020-07-30

Safey Pocket Spirometer

Applicant Safey Medical Devices Pvt, Ltd.

K number K201002

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BZG 2020-07-27

Vitalograph Model 2120 In2itive eDiary

Applicant Vitalograph Ireland, Ltd.

K number K200550

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BZG 2020-01-02

Air Next

Applicant Nuvoair AB

K number K183089

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BZG 2019-10-03

Asthma Monitor AM3

Applicant Eresearch Technology

K number K183479

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BZG 2019-09-10

Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option

Applicant Welch Allyn, Inc.

K number K191013

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BZG 2019-06-06

ComPAS2 (Computerized Pulmonary Analysis System)

Applicant Morgan Scientific, Inc.

K number K190568

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BZG 2018-07-13

Pulmonx Chartis Tablet Console

Applicant Pulmonx Corporation

K number K180011

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BZG 2017-03-24

GoSpiro

Applicant Monitored Therapeutics, Inc.

K number K163249

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BZG 2017-01-05

EasyOne Air Spirometer

Applicant Ndd Medizintechnik AG

K number K161536

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BZG 2016-10-20

Q13 SPIROLYSER®

Applicant Fim Medical

K number K161676

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BZG 2016-10-07

SpiroScout

Applicant Ganshorn Medizin Electronic GmbH

K number K160116

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BZG 2016-08-26

Vitalograph Model 6300 micro

Applicant Vitalograph (Ireland) , Ltd.

K number K160253

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BZG 2016-01-12

IQSense Flow Sensor Mouthpiece

Applicant Sdi Diagnostics, Inc.

K number K150515

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BZG 2013-11-15

SPM-300

Applicant Bionet Co., Ltd.

K number K130322

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BZG 2013-10-30

SPIROTEL

Applicant Mir Medical Intl. Research Srl

K number K130784

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BZG 2013-09-10

CCS-200 SPIROMETER

Applicant Benson Medical Instruments Co.

K number K123896

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BZG 2012-10-04

MINISPIR

Applicant Mir Medical Intl. Research Srl

K number K122384

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BZG 2012-04-19

ORBIT

Applicant National Biomedical, LLC Dba Qrs Diagnostic

K number K120880

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BZG 2012-04-13

MICRO I

Applicant Carefusion Germany 234 GmbH

K number K113096

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BZG 2011-11-21

SPIRODOC

Applicant Medical International Research USA, Inc.

K number K103530

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BZG 2011-11-10

CHARTIS CONSOLE

Applicant Pulmonx, Inc.

K number K111764

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BZG 2011-11-09

SPIRO PD

Applicant Pmd Healthcare

K number K103575

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BZG 2011-10-20

ALERKAN SPIROMETRY FILTER

Applicant Alerkan, Ltd.

K number K111587

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BZG 2011-03-07

MICRO DIARY SPIROMETER

Applicant Viasys Respiratory Care, Inc.

K number K100928

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BZG 2011-02-10

MASTERSCREEN IOS

Applicant Carefusion Germany 234 GmbH

K number K101873

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BZG 2010-10-16

VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120

Applicant Vitalograph (Ireland) , Ltd.

K number K100687

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BZG 2010-07-16

ASTRASONIC SPIROMETER, MODEL 29-8000

Applicant Sdi Diagnostics, Inc.

K number K092813

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BZG 2010-02-26

SPIROPALM

Applicant Cosmed Srl

K number K093174

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BZG 2010-01-13

ASTHMA MONITOR AM3

Applicant Carefusion Germany 234 GmbH

K number K092890

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BZG 2009-07-23

CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105

Applicant Chest M.I., Inc.

K number K090646

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BZG 2009-06-25

CHARTIS CONSOLE

Applicant Pulmonx, Inc.

K number K083199

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BZG 2009-06-02

EASY ON-PC SPIROMETER

Applicant Ndd Medizitechnik AG

K number K090034

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BZG 2009-05-06

ASTHMA MONITOR MODEL, AM1

Applicant Cardinal Health Germany 234 GmbH

K number K090486

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BZG 2009-03-09

WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62

Applicant Welch Allyn, Inc.

K number K082478

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BZG 2009-03-02

THE PFT FILTER

Applicant Pulmonary Filtration Technologies, LLC

K number K083233

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BZG 2009-02-23

INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500)

Applicant Innovision A/S

K number K083879

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BZG 2009-01-21

SPIRO-MASTER PC-10 SPIROMETRY SYSTEM

Applicant Chest M.I., Inc.

K number K080921

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BZG 2008-12-17

MODIFICATION TO MINISPIR, SPIROLAB III

Applicant Mir Medical Intl. Research Srl

K number K082766

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BZG 2008-06-04

VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6)

Applicant Vitalograph (Ireland) , Ltd.

K number K073155

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BZG 2008-04-24

MEDDORNA WIRELESS PRN SPIROMETER 100

Applicant Meddorna, LLC

K number K072722

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BZG 2007-12-26

SPIROBANK G

Applicant Mir Medical Intl. Research Srl

K number K072979

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BZG 2007-01-31

ASTRA 300

Applicant Sdi Diagnostics, Inc.

K number K061571

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BZG 2007-01-26

ASTRAGUARD PULMONARY FUNCTION FILTER

Applicant Sdi Diagnostics, Inc.

K number K062913

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BZG 2006-12-14

PULMOLIFE

Applicant Micro Medical, Ltd.

K number K061283

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BZG 2006-12-11

MINISPIR; SPIROLAB III

Applicant Mir Medical Intl. Research Srl

K number K061875

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BZG 2006-12-01

SPIROBANK II

Applicant Mir Medical Intl. Research Srl

K number K061712

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BZG 2006-03-16

SPIROLAB, SPIROLAB II

Applicant Mir Medical Intl. Research Srl

K number K052140

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BZG 2006-01-12

FLOWHANDY ZAN100 USB

Applicant Zan Messgerate GmbH

K number K052176

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BZG 2005-11-17

KOKO LEGEND

Applicant Pulmonary Data Services, Inc.

K number K051572

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BZG 2005-09-08

WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE

Applicant Welch Allyn, Inc.

K number K052158

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BZG 2005-09-01

MODEL 2800 PFT FILTER

Applicant Air Safety, Ltd.

K number K051712

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BZG 2005-08-29

POLYTECH PULMONARY FUNCTION FILTER

Applicant Polytechnic Resources, Inc.

K number K042758

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BZG 2005-07-19

SPIROTEL

Applicant Mir Medical Intl. Research Srl

K number K043528

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BZG 2005-06-23

ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50

Applicant Fim Medical

K number K050424

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BZG 2005-05-04

SPIRO'AIR

Applicant Morgan Scientific, Inc.

K number K042595

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BZG 2005-03-23

ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN

Applicant Clement Clarke Intl., Ltd.

K number K042058

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BZG 2004-03-10

LOTUS PULMONARY FUNCTION FILTER, MODELS CPF 101, CPF 102, CPF 103

Applicant Custom Plastic Products

K number K033518

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BZG 2004-01-30

FLOSENSE II, MODEL 29-8040

Applicant Sdi Diagnostics, Inc.

K number K033939

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BZG 2003-12-09

SPIROTEL, MODEL 29-1020

Applicant Sdi Diagnostics, Inc.

K number K031643

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BZG 2003-12-01

MICROLAB SPIROMETER

Applicant Micro Direct, Inc.

K number K031102

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BZG 2003-05-14

GEM; HAWK; EAGLE; MODELS 004110, 0044120, 004130

Applicant Collins Medical, Inc.

K number K030917

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BZG 2003-03-21

IQTEQ SPIROMETER

Applicant Iqteq Development

K number K020102

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BZG 2003-03-14

GEM, MODEL 004110

Applicant Collins Medical, Inc.

K number K030464

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BZG 2002-12-18

PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE

Applicant Puritan Bennett Corp.

K number K023225

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BZG 2002-10-18

COMPAS

Applicant Morgan Scientific, Inc.

K number K021200

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BZG 2002-10-04

KOKOMATE

Applicant Ferraris Respiratory, Inc.

K number K022276

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BZG 2002-09-27

PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM

Applicant Puritan Bennett Corp.

K number K022103

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BZG 2002-09-24

PULMOLAB EX671 EXERCISE TESTING SYSTEM

Applicant Morgan Medical , Ltd.

K number K020280

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BZG 2002-07-24

CLINDATALINK VERSION 1.0 FOR SPIROMETRY

Applicant Compleware Corp.

K number K020004

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BZG 2002-03-14

EMS PULMONARY FUNCTION TESTING FILTER

Applicant Engineered Medical Systems

K number K013123

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BZG 2002-03-05

SPL-50 SPIROLYSER

Applicant Fim Medical

K number K010761

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BZG 2002-02-11

SPIROLAB II, MODEL 29

Applicant Sdi Diagnostics, Inc.

K number K013812

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BZG 2002-01-30

COMPAS AS (COMPUTERIZED PULMONARY ANALYSIS SYSTEM)

Applicant Morgan Scientific, Inc.

K number K013752

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BZG 2001-10-12

SDI SB OFFICE, MODEL 29-

Applicant Sdi Diagnostics, Inc.

K number K011470

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BZG 2001-01-18

PC FLOW +

Applicant Spirometrics Medical Equipment Co.

K number K001528

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BZG 2000-11-29

SENSAIRE DIAGNOSTIC SPIROMETER

Applicant Qrs Diagnostic, LLC

K number K001278

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BZG 2000-11-08

BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGE

Applicant Brentwood Medical Technology Corp.

K number K002499

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BZG 2000-09-08

VITALOGRAPH BASE STATION

Applicant Vitalograph, Inc.

K number K000599

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BZG 2000-05-23

NDD MEDICAL TECHNOLOGIES EASYONE SPIROMETER: FRONTLINE MODEL 2000 AND DIAGNOSTIC MODEL 2001

Applicant Ndd Medical Technologies

K number K993921

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BZG 2000-05-12

SPIROVIT SP-2, PNEUMOCHECK II

Applicant Schiller AG

K number K992823

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BZG 1999-09-13

COLLINS CPL

Applicant Collins Medical, Inc.

K number K992743

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BZG 1999-04-30

SPIROVIT, MODEL SP-250

Applicant Schiller AG

K number K984031

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BZG 1998-12-21

MIR SPIROBANK SPIROMETER

Applicant Mir Medical Intl. Research Srl

K number K983909

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BZG 1998-12-01

CAIRD TECHNOLOGY SPIROMETER

Applicant Caird Technology

K number K971336

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BZG 1998-11-24

FLOWMATE II PLUS, MODEL #4000

Applicant Spirometrics Medical Equipment Co.

K number K982956

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BZG 1998-10-28

SPIROCARD

Applicant Qrs Diagnostic, LLC

K number K973138

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BZG 1998-08-14

ASTHMA MONITOR AM2

Applicant Erich Jaeger GmbH & Co. KG

K number K980876

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