Sentinel Camera— 510(k) K243664
Substantially EquivalentAi Optics
FDA 510(k) clearance K243664 for Sentinel Camera, Substantially Equivalent on 2024-12-17. Applicant: Ai Optics. Device class: 2.
Clearance details
- Applicant
- Ai Optics
- 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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