EyeArt v2.2.0— 510(k) K223357
Substantially EquivalentEyenuk, Inc.
FDA 510(k) clearance K223357 for EyeArt v2.2.0, Substantially Equivalent on 2023-06-16. Applicant: Eyenuk, Inc.. Device class: 2.
Clearance details
- Applicant
- Eyenuk, Inc.
- Product code
- Code PIB
- Device class
- Class 2
- Regulation
- 21 CFR 886.1100
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Angeles, CA, US
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