K251245
- 510(k) number
- K251245
- Device name
- OxyMinder Pro (10310)
- Applicant
- Bio-Med Device, Inc. CT · US
- Product code
- CCL — Analyzer, Gas, Oxygen, Gaseous-Phase
- Decision date
- 2025-08-11
- Date received
- 2025-04-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K251245.pdf
Official FDA record: K251245
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.