BTK
- Product code
- BTK
- Device name
- Strap, Head, Gas Mask
- Device class
- Class 1
- 21 CFR
- 21 CFR 868.5560
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (last 3 years)
- 6
Official FDA classification page: BTK
Classification and pathway per current FDA publications. Data from openFDA (CC0).