P200DTx— 510(k) K142897
Substantially EquivalentOptos Plc.
FDA 510(k) clearance K142897 for P200DTx, Substantially Equivalent on 2015-01-16. Applicant: Optos Plc.. Device class: 2.
Clearance details
- Applicant
- Optos Plc.
- Product code
- Code MYC
- Device class
- Class 2
- Regulation
- 21 CFR 886.1570
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dunfermline, GB
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