Product code BZG
- Device name
- Spirometer, Diagnostic
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.1840
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251777 | MESI mTABLET SPIRO | Mesi D.O.O. | 2026-03-02 |
| K241843 | TD-7301 Spirometer (TD-7301) | Gostar Co., Ltd. | 2024-11-20 |
| K231416 | Air Next (NVD-02) | Nuvoair AB | 2024-01-18 |
| K230501 | Spirobank Oxi | Mir Medical International Research USA | 2023-12-15 |
| K230178 | EasyOne Sky Spirometer | Ndd Medizintechnik AG | 2023-10-19 |
| K222525 | Alveoair Digital Spirometer | Roundworks Technologies Private Limited | 2023-08-28 |
| K222443 | Air Smart Extra Spirometer | Feellife Health, Inc. | 2023-08-09 |
| K213754 | SpiroHome Personal, SpiroHome Clinic | Inofab Saglik Teknolojileri A.S | 2023-06-12 |
| K213872 | ComPAS2 | Morgan Scientific, Inc. | 2022-07-15 |
| K212938 | Vitalograph Model 6000 Alpha | Vitalograph Ireland, Ltd. | 2022-01-26 |
| K201493 | Spirometer | Mehow Innovative, Ltd. | 2021-06-10 |
| K202837 | GoSpiro | Monitored Therapeutics, Inc. | 2020-12-04 |
| K201562 | Spirotrac | Vitalograph Ireland, Ltd. | 2020-10-14 |
| K201002 | Safey Pocket Spirometer | Safey Medical Devices Pvt, Ltd. | 2020-07-30 |
| K200550 | Vitalograph Model 2120 In2itive eDiary | Vitalograph Ireland, Ltd. | 2020-07-27 |
| K183089 | Air Next | Nuvoair AB | 2020-01-02 |
| K183479 | Asthma Monitor AM3 | Eresearch Technology | 2019-10-03 |
| K191013 | Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option | Welch Allyn, Inc. | 2019-09-10 |
| K190568 | ComPAS2 (Computerized Pulmonary Analysis System) | Morgan Scientific, Inc. | 2019-06-06 |
| K180011 | Pulmonx Chartis Tablet Console | Pulmonx Corporation | 2018-07-13 |
| K163249 | GoSpiro | Monitored Therapeutics, Inc. | 2017-03-24 |
| K161536 | EasyOne Air Spirometer | Ndd Medizintechnik AG | 2017-01-05 |
| K161676 | Q13 SPIROLYSER® | Fim Medical | 2016-10-20 |
| K160116 | SpiroScout | Ganshorn Medizin Electronic GmbH | 2016-10-07 |
| K160253 | Vitalograph Model 6300 micro | Vitalograph (Ireland) , Ltd. | 2016-08-26 |
| K150515 | IQSense Flow Sensor Mouthpiece | Sdi Diagnostics, Inc. | 2016-01-12 |
| K142642 | Vitalograph Model 6600 Compact | Vitalograph (Ireland) , Ltd. | 2015-06-30 |
| K142812 | Vitalograph Model 6800 Pneumotrac | Vitalograph (Ireland) , Ltd. | 2015-06-29 |
| K120577 | MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DX | Medikro OY | 2015-06-24 |
| K150137 | SpiroThor | Cohero Health, LLC | 2015-05-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07640142190554 | EasyOne Sky Spirometer | NDD Medizintechnik AG | 2026-04-21 |
| 08052990320455 | MIR | MIR MEDICAL INTERNATIONAL RESEARCH SPA | 2026-04-03 |
| 08052990320431 | MIR | MIR MEDICAL INTERNATIONAL RESEARCH SPA | 2026-04-03 |
| 08052990320387 | MIR | MIR MEDICAL INTERNATIONAL RESEARCH SPA | 2026-04-03 |
| 08052990320370 | MIR | MIR MEDICAL INTERNATIONAL RESEARCH SPA | 2026-04-03 |
| 08052990320363 | MIR | MIR MEDICAL INTERNATIONAL RESEARCH SPA | 2026-04-03 |
| 08052990320325 | MIR | MIR MEDICAL INTERNATIONAL RESEARCH SPA | 2026-04-03 |
| 08052990320318 | MIR | MIR MEDICAL INTERNATIONAL RESEARCH SPA | 2026-04-03 |
| 08052990320295 | MIR | MIR MEDICAL INTERNATIONAL RESEARCH SPA | 2026-04-03 |
| 08052990320288 | MIR | MIR MEDICAL INTERNATIONAL RESEARCH SPA | 2026-04-03 |
| 07613365501230 | PowerCube+ Series | Ganshorn Medizin Electronic GmbH | 2025-03-31 |
| 07613365501254 | PowerCube+ Series | Ganshorn Medizin Electronic GmbH | 2025-03-31 |
| 07613365501247 | PowerCube+ Series | Ganshorn Medizin Electronic GmbH | 2025-03-31 |
| 07613365501223 | PowerCube+ Series | Ganshorn Medizin Electronic GmbH | 2025-03-31 |
| 07613365501216 | PowerCube+ Series | Ganshorn Medizin Electronic GmbH | 2025-03-31 |
| 07613365501209 | PowerCube+ Series | Ganshorn Medizin Electronic GmbH | 2025-03-31 |
| 07613365501193 | PowerCube+ Series | Ganshorn Medizin Electronic GmbH | 2025-03-31 |
| 07613365501094 | PowerCube+ Series | Ganshorn Medizin Electronic GmbH | 2024-12-20 |
| 07613365501070 | PowerCube+ Series | Ganshorn Medizin Electronic GmbH | 2024-12-20 |
| 07613365501032 | PowerCube+ Series | Ganshorn Medizin Electronic GmbH | 2024-12-20 |
| 07613365501018 | PowerCube+ Series | Ganshorn Medizin Electronic GmbH | 2024-12-20 |
| 07613365500431 | PowerCube+ Series | Ganshorn Medizin Electronic GmbH | 2024-12-20 |
| 07613365500400 | PowerCube+ Series | Ganshorn Medizin Electronic GmbH | 2024-12-20 |
| 07613365500301 | PowerCube+ Series | Ganshorn Medizin Electronic GmbH | 2024-12-20 |
| 08052990320448 | MIR | MIR MEDICAL INTERNATIONAL RESEARCH SPA | 2016-11-24 |
| 08050612840008 | Resmon PRO FULL | RESTECH SRL | 2016-09-24 |
| 07613365000467 | Diagnostic Station DS20 | Schiller AG | 2016-09-19 |
| 07613365000498 | Diagnostic Station DS20 | Schiller AG | 2016-09-19 |
| 07613365000481 | Diagnostic Station DS20 | Schiller AG | 2016-09-19 |
| 07613365000474 | Diagnostic Station DS20 | Schiller AG | 2016-09-19 |