BZG
- Product code
- BZG
- Device name
- Spirometer, Diagnostic
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.1840
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 228 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251777 | 2026-03-02 | Mesi D.O.O. | MESI mTABLET SPIRO | |
| K241843 | 2024-11-20 | Gostar Co., Ltd. | TD-7301 Spirometer (TD-7301) | FDA |
| K231416 | 2024-01-18 | Nuvoair AB | Air Next (NVD-02) | |
| K230501 | 2023-12-15 | Mir Medical International Research USA | Spirobank Oxi | |
| K230178 | 2023-10-19 | Ndd Medizintechnik AG | EasyOne Sky Spirometer |
Official FDA classification page: BZG
Classification and pathway per current FDA publications. Data from openFDA (CC0).