K251583
- 510(k) number
- K251583
- Device name
- Ambu® Virobac II® Exhalation Filter
- Applicant
- Ambu A/S DK
- Product code
- CAH — Filter, Bacterial, Breathing-Circuit
- Decision date
- 2026-04-30
- Date received
- 2025-05-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K251583.pdf
Official FDA record: K251583
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.