BZH
- Product code
- BZH
- Device name
- Meter, Peak Flow, Spirometry
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.1860
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 6
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 81 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (6)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253180 | 2026-06-23 | Microlife Corporation | Microlife Digital Peak Flow Meter, Model PF200B (PF2… | |
| K252802 | 2026-05-29 | Shenzhen Bi-Rich Medical Devices Co., … | Peak Flow Meter (PF-10(BR-PEF231)) | |
| K241338 | 2024-12-31 | Chongqing Moffy Innovation Technology … | Peak Flow Meter | — |
| K232588 | 2024-11-25 | Knox Medical Diagnostics | Aluna 2 | |
| K230423 | 2024-02-23 | Taian Dalu Medical Instrument Co., Ltd… | Electronic Peak Flow Meter | FDA |
| K222810 | 2023-12-19 | Gostar Co., Ltd. | TD-7301 Peak Flow meter | FDA |
Official FDA classification page: BZH
Classification and pathway per current FDA publications. Data from openFDA (CC0).