CORVIS ST— 510(k) K113066

Substantially Equivalent

Oculus Optikgerate GmbH

FDA 510(k) clearance K113066 for CORVIS ST, Substantially Equivalent on 2012-11-08. Applicant: Oculus Optikgerate GmbH. Device class: 2.

Clearance details

Applicant: Oculus Optikgerate GmbH
Product code: Code HKX
Device class: Class 2
Regulation: 21 CFR 886.1930
Advisory panel: Ophthalmic
Date received: 2011-10-17
Decision date: 2012-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wetzlar, DE

Download summary PDF View on FDA.gov ↗

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