BTL
- Product code
- BTL
- Device name
- Ventilator, Emergency, Powered (Resuscitator)
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.5925
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- Flag
- Life-sustaining / life-supporting
- 510(k) clearances (last 3 years)
- 100
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K242769 | 2025-04-04 | Draegerwerk AG & CO Kgaa | VentStar Resus heated (N) (MP17030); VentStar Autobr |
Official FDA classification page: BTL
Classification and pathway per current FDA publications. Data from openFDA (CC0).