OCT-Camera ID 21101A3— 510(k) K200516

Name: FDA 510(k) clearance K200516
Creator: U.S. Food and Drug Administration
Published: 2020-09-02

Substantially Equivalent

Optomedical Technologies GmbH

FDA 510(k) clearance K200516 for OCT-Camera ID 21101A3, Substantially Equivalent on 2020-09-02. Applicant: Optomedical Technologies GmbH. Device class: 2.

Clearance details

Applicant: Optomedical Technologies GmbH
Product code: Code OBO
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 2020-03-02
Decision date: 2020-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Luebeck, DE

Download summary PDF View on FDA.gov ↗

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