ICAM FUNDUS CAMERA— 510(k) K122572
Substantially EquivalentOptovue, Inc.
FDA 510(k) clearance K122572 for ICAM FUNDUS CAMERA, Substantially Equivalent on 2013-01-11. Applicant: Optovue, Inc.. Device class: 2.
Clearance details
- Applicant
- Optovue, 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
- Fremont, CA, US
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