FDA.reportPublic FDA data

Diagnostic spirometer, professional

Definition
An electrically-powered device designed exclusively for professional use to measure several or all respiratory gas volume and flow parameters for evaluation of basic pulmonary function [e.g., vital capacity (VC), peak expiratory flow (PEF), forced expiratory volume (FEV), and forced expiratory flow (FEF)]; it may also perform pulse oximetry. It is typically a hand-held instrument with a mouthpiece which communicates with a computerized unit (e.g., analysis system, graph recorder, tablet). It is used to help diagnosis and monitoring of chronic pulmonary disorders such as asthma, emphysema, or bronchitis, and potentially heart disorders.
GUDID devices
154
Last updated
2026-06-12 06:05:18

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00851845007248comPAS2VITALOGRAPH (IRELAND) LIMITED917042026-06-03
00607411600043N/ASALTER LABS6020-0-252016-09-24
00732094130348703554 Spirometer Kit (USB)Medikro OyM94682026-04-21
00810016250340MGC DiagnosticsMEDICAL GRAPHICS CORPORATION762042-0032019-02-22
00851845007163ComPAS2MORGAN SCIENTIFIC, INC2022.2.12022-12-09
04057155000412ERT PTeResearchTechnology GmbHERT PT2019-02-25
04057155000801SpiroWayeResearchTechnology GmbHSpiroWay2024-07-22
04057155000948ERT PTeResearchTechnology GmbHERT PT2025-08-11
04250892908618JaegerJaeger Medical GmbHV-707254-132025-10-31
06420099000042M921, Medikro® SpiroStar DXMedikro OyM94702026-04-21
06420099000219703552 Spirometer Kit (Serial)Medikro OyM94712026-04-21
06420099000448M929, Medikro® SpiroStar USBMedikro OyM94792026-04-21
06420099000820M913, Medikro® NanoMedikro OyM94872018-07-13
06420099000837M915, Medikro® ProMedikro OyM94882018-07-13
06420099000851M914, Medikro® PrimoMedikro OyM94922018-07-13
06420099001094M915-PCD, PCD Spirometer KitMedikro OyM9488-PCD2019-11-29
07640142190554EasyOne Sky SpirometerNDD Medizintechnik AG2800-12026-04-21
08809276943729Spiro HandleBionet CO,LTDSpiro Handle2021-07-15
10885632429774HalyardOWENS & MINOR DISTRIBUTION, INC.561782025-02-06
10885632429781HalyardOWENS & MINOR DISTRIBUTION, INC.561792025-02-06
10885632429798HalyardOWENS & MINOR DISTRIBUTION, INC.561802025-02-06
10885632429804HalyardOWENS & MINOR DISTRIBUTION, INC.561812025-02-06
10889483570807AirLife™AIRLIFE001901A2025-02-11
10889483570821AirLife™AIRLIFE001903A2025-02-11
15099169633015MicroVITALOGRAPH (IRELAND) LIMITED63002017-02-21
15099169633039MicroVITALOGRAPH (IRELAND) LIMITED63002017-02-21
15099169633107MicroVITALOGRAPH (IRELAND) LIMITED63002017-02-21
15099169633305MicroVITALOGRAPH (IRELAND) LIMITED63002017-11-14
15099169633312MicroVITALOGRAPH (IRELAND) LIMITED63002021-04-16
15099169635200MicroVITALOGRAPH (IRELAND) LIMITED63002017-02-21
15099169650005AlphaVITALOGRAPH (IRELAND) LIMITED60002017-04-14
15099169650029AlphaVITALOGRAPH (IRELAND) LIMITED60002017-04-20
15099169650036AlphaVITALOGRAPH (IRELAND) LIMITED60002017-04-20
15099169650043AlphaVITALOGRAPH (IRELAND) LIMITED60002017-04-20
15099169650050AlphaVITALOGRAPH (IRELAND) LIMITED60002017-04-20
15099169650067AlphaVITALOGRAPH (IRELAND) LIMITED60002017-04-21
15099169650074AlphaVITALOGRAPH (IRELAND) LIMITED60002017-04-21
15099169650081AlphaVITALOGRAPH (IRELAND) LIMITED60002017-04-21
15099169650098AlphaVITALOGRAPH (IRELAND) LIMITED60002017-04-21
15099169650104AlphaVITALOGRAPH (IRELAND) LIMITED60002017-04-29
15099169650128AlphaVITALOGRAPH (IRELAND) LIMITED60002017-04-29
15099169650135AlphaVITALOGRAPH (IRELAND) LIMITED60002017-04-29
15099169650142AlphaVITALOGRAPH (IRELAND) LIMITED60002017-04-29
15099169650159AlphaVITALOGRAPH (IRELAND) LIMITED60002017-04-29
15099169650173AlphaVITALOGRAPH (IRELAND) LIMITED60002017-04-29
15099169650180AlphaVITALOGRAPH (IRELAND) LIMITED60002017-04-29
15099169650197AlphaVITALOGRAPH (IRELAND) LIMITED60002017-04-29
15099169650609AlphaVITALOGRAPH (IRELAND) LIMITED60002017-04-29
15099169650616AlphaVITALOGRAPH (IRELAND) LIMITED60002017-04-29
15099169650623AlphaVITALOGRAPH (IRELAND) LIMITED60002017-04-29
15099169650708AlphaVITALOGRAPH (IRELAND) LIMITED60002017-04-29
15099169650739AlphaVITALOGRAPH (IRELAND) LIMITED60002017-04-29
15099169650777AlphaVITALOGRAPH (IRELAND) LIMITED60002017-04-29
15099169650982AlphaVITALOGRAPH (IRELAND) LIMITED60002017-04-29
15099169650999AlphaVITALOGRAPH (IRELAND) LIMITED60002017-04-29
15099169654034AlphaVITALOGRAPH (IRELAND) LIMITED60002017-05-03
15099169654133AlphaVITALOGRAPH (IRELAND) LIMITED60002017-05-03
15099169655024AlphaVITALOGRAPH (IRELAND) LIMITED60002017-05-03
15099169655048AlphaVITALOGRAPH (IRELAND) LIMITED60002017-05-03
15099169655062AlphaVITALOGRAPH (IRELAND) LIMITED60002017-05-03
15099169655086AlphaVITALOGRAPH (IRELAND) LIMITED60002017-05-03
15099169655093AlphaVITALOGRAPH (IRELAND) LIMITED60002017-05-03
15099169655123AlphaVITALOGRAPH (IRELAND) LIMITED60002017-05-03
15099169655185AlphaVITALOGRAPH (IRELAND) LIMITED60002017-05-03
15099169655192AlphaVITALOGRAPH (IRELAND) LIMITED60002017-05-03
15099169655994AlphaVITALOGRAPH (IRELAND) LIMITED60002017-05-03
15099169656045AlphaVITALOGRAPH (IRELAND) LIMITED60002017-05-03
15099169656069AlphaVITALOGRAPH (IRELAND) LIMITED60002017-05-03
15099169656083AlphaVITALOGRAPH (IRELAND) LIMITED60002017-05-03
15099169656090AlphaVITALOGRAPH (IRELAND) LIMITED60002017-05-03
15099169656106AlphaVITALOGRAPH (IRELAND) LIMITED60002017-05-03
15099169656113AlphaVITALOGRAPH (IRELAND) LIMITED60002017-05-03
15099169656120AlphaVITALOGRAPH (IRELAND) LIMITED60002017-05-03
15099169656991AlphaVITALOGRAPH (IRELAND) LIMITED60002017-05-03
15099169678016COMPACTVITALOGRAPH (IRELAND) LIMITED66002020-09-30
15099169690025AlphaVITALOGRAPH (IRELAND) LIMITED60002022-03-04
15099169770529PneumotracVITALOGRAPH (IRELAND) LIMITED68002017-11-15
15099169777320PneumotracVITALOGRAPH (IRELAND) LIMITED68002017-11-15
15099169777528PneumotracVITALOGRAPH (IRELAND) LIMITED68002017-11-15
15099169777573PneumotracVITALOGRAPH (IRELAND) LIMITED68002021-04-16