The BAG manual resuscitator and accessories— 510(k) K251631
Substantially EquivalentLaerdal Medical AS
FDA 510(k) clearance K251631 for The BAG manual resuscitator and accessories, Substantially Equivalent on 2025-11-24. Applicant: Laerdal Medical AS. Device class: 2.
Clearance details
- Applicant
- Laerdal Medical AS
- Product code
- Product code BTM
- Device class
- Class 2
- Regulation
- 21 CFR 868.5915
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Stavanger, NO
Recent devices under product code BTM
view allMore clearances from Laerdal Medical AS
view allAdverse events under product code BTM
product code BTM- Death
- 19
- Other
- 2
- Total
- 21
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.