OxyMinder Pro (10310)— 510(k) K251245
Substantially EquivalentBio-Med Device, Inc.
FDA 510(k) clearance K251245 for OxyMinder Pro (10310), Substantially Equivalent on 2025-08-11. Applicant: Bio-Med Device, Inc..
Clearance details
- Applicant
- Bio-Med Device, Inc.
- Product code
- Code CCL
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Guilford, CT, US
Adverse events under product code CCL
product code CCL- Other
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.