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.. Device class: 2.
Clearance details
- Applicant
- Optain Health, Inc.
- Product code
- Code HKI
- Device class
- Class 2
- Regulation
- 21 CFR 886.1120
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
Recent devices under product code HKI
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