PACHYCAM— 510(k) K041841

Substantially Equivalent

Oculus Optikgerate GmbH

FDA 510(k) clearance K041841 for PACHYCAM, Substantially Equivalent on 2005-01-28. Applicant: Oculus Optikgerate GmbH. Device class: 2.

Clearance details

Applicant: Oculus Optikgerate GmbH
Product code: Code MXK
Device class: Class 2
Regulation: 21 CFR 886.1850
Advisory panel: Ophthalmic
Date received: 2004-07-08
Decision date: 2005-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wetzla-Dutenhofen, 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.