OPTOS ADVANCE— 510(k) K113696
Substantially EquivalentOptos Plc.
FDA 510(k) clearance K113696 for OPTOS ADVANCE, Substantially Equivalent on 2012-05-25. Applicant: Optos Plc.. Device class: 2.
Clearance details
- Applicant
- Optos Plc.
- Product code
- Code NFJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Washington, DC, US
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