K243394
- 510(k) number
- K243394
- Device name
- AF531 Oro-Nasal SE Face Mask
- Applicant
- Respironics, Inc. PA · US
- Product code
- CBK — Ventilator, Continuous, Facility Use
- Decision date
- 2024-12-30
- Date received
- 2024-10-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K243394.pdf
Official FDA record: K243394
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.