Resolve Fundus Camera— 510(k) K250683
Substantially EquivalentOptain Health, Inc.
FDA 510(k) clearance K250683 for Resolve Fundus Camera, Substantially Equivalent on 2025-04-30. Applicant: Optain Health, Inc..
Clearance details
- Applicant
- Optain Health, Inc.
- Product code
- Code HKI
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.