K251631
- 510(k) number
- K251631
- Device name
- The BAG manual resuscitator and accessories
- Applicant
- Laerdal Medical AS NO
- Product code
- BTM — Ventilator, Emergency, Manual (Resuscitator)
- Decision date
- 2025-11-24
- Date received
- 2025-05-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K251631.pdf
Official FDA record: K251631
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.