DAYTONA ICG (P200TICG)— 510(k) K134039

Substantially Equivalent

Optos Plc.

FDA 510(k) clearance K134039 for DAYTONA ICG (P200TICG), Substantially Equivalent on 2014-04-11. 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: 2013-12-31
Decision date: 2014-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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