P200TxE— 510(k) K190732

Substantially Equivalent

Optos Plc.

FDA 510(k) clearance K190732 for P200TxE, Substantially Equivalent on 2019-07-31. Applicant: Optos Plc.. Device class: 2.

Clearance details

Applicant: Optos Plc.
Product code: Code OBO
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 2019-03-21
Decision date: 2019-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dunfermline, GB

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.