PARKONE— 510(k) K073508

Substantially Equivalent

Oculus Optikgerate GmbH

FDA 510(k) clearance K073508 for PARKONE, Substantially Equivalent on 2008-09-11. 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: 2007-12-13
Decision date: 2008-09-11
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.