BZG — Spirometer, Diagnostic Class II
FDA product code BZG covers "Spirometer, Diagnostic", a Class II medical device regulated under 21 CFR 868.1840. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |