SPECTRAL OCT/SLO— 510(k) K080460
Substantially EquivalentOpko Health, Inc.
FDA 510(k) clearance K080460 for SPECTRAL OCT/SLO, Substantially Equivalent on 2008-11-14. Applicant: Opko Health, Inc.. Device class: 2.
Clearance details
- Applicant
- Opko Health, Inc.
- Product code
- Code OBO
- Device class
- Class 2
- Regulation
- 21 CFR 886.1570
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
Recent devices under product code OBO
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