Eyenez Ophthalmic Camera— 510(k) K161727
Substantially EquivalentEyenez, LLC
FDA 510(k) clearance K161727 for Eyenez Ophthalmic Camera, Substantially Equivalent on 2016-10-04. Applicant: Eyenez, LLC. Device class: 2.
Clearance details
- Applicant
- Eyenez, LLC
- 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
- Pasadena, CA, US
Recent devices under product code HKI
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