BZG — Spirometer, Diagnostic Class II
FDA Device Classification
Classification Details
- Product Code
- BZG
- Device Class
- Class II
- Regulation Number
- 868.1840
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
| K251777 | mesi | MESI mTABLET SPIRO | March 2, 2026 |
| K241843 | gostar co | TD-7301 Spirometer (TD-7301) | November 20, 2024 |
| K231416 | nuvoair | Air Next (NVD-02) | January 18, 2024 |
| K230501 | mir medical international research usa | Spirobank Oxi | December 15, 2023 |
| K230178 | ndd medizintechnik | EasyOne Sky Spirometer | October 19, 2023 |
| K222525 | roundworks technologies private limited | Alveoair Digital Spirometer | August 28, 2023 |
| K222443 | feellife health | Air Smart Extra Spirometer | August 9, 2023 |
| K213754 | inofab saglik teknolojileri a.s | SpiroHome Personal, SpiroHome Clinic | June 12, 2023 |
| K213872 | morgan scientific | ComPAS2 | July 15, 2022 |
| K212938 | vitalograph ireland | Vitalograph Model 6000 Alpha | January 26, 2022 |
| K201493 | mehow innovative | Spirometer | June 10, 2021 |
| K202837 | monitored therapeutics | GoSpiro | December 4, 2020 |
| K201562 | vitalograph ireland | Spirotrac | October 14, 2020 |
| K201002 | safey medical devices pvt | Safey Pocket Spirometer | July 30, 2020 |
| K200550 | vitalograph ireland | Vitalograph Model 2120 In2itive eDiary | July 27, 2020 |
| K183089 | nuvoair | Air Next | January 2, 2020 |
| K183479 | eresearch technology | Asthma Monitor AM3 | October 3, 2019 |
| K191013 | welch allyn | Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option | September 10, 2019 |
| K190568 | morgan scientific | ComPAS2 (Computerized Pulmonary Analysis System) | June 6, 2019 |
| K180011 | pulmonx corporation | Pulmonx Chartis Tablet Console | July 13, 2018 |