K250671
- 510(k) number
- K250671
- Device name
- FreeStyle Comfort (AS200 / FreeStyle Comfort)
- Applicant
- Caire, Inc. GA · US
- Product code
- CAW — Generator, Oxygen, Portable
- Decision date
- 2025-07-11
- Date received
- 2025-03-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K250671.pdf
Official FDA record: K250671
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.