BZK
- Product code
- BZK
- Device name
- Spirometer, Monitoring (W/Wo Alarm)
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.1850
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 61
Official FDA classification page: BZK
Classification and pathway per current FDA publications. Data from openFDA (CC0).