3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM— 510(k) K083316
Substantially EquivalentTopcon Medical Systems, Inc.
FDA 510(k) clearance K083316 for 3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM, Substantially Equivalent on 2009-03-13. Applicant: Topcon Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Topcon Medical Systems, 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
- Cincinnati, OH, US
Recent devices under product code OBO
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