OCT-Camera ID 21101A3

Tomography, Optical Coherence

OptoMedical Technologies GmbH

The following data is part of a premarket notification filed by Optomedical Technologies Gmbh with the FDA for Oct-camera Id 21101a3.

Pre-market Notification Details

Device IDK200516
510k NumberK200516
Device Name:OCT-Camera ID 21101A3
ClassificationTomography, Optical Coherence
Applicant OptoMedical Technologies GmbH Maria-Goeppert-Strasse 9 Luebeck,  DE 23562
ContactJulia Behrens
CorrespondentOliver Eikenberg
Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin,  TX  78746
Product CodeOBO  
CFR Regulation Number886.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-02
Decision Date2020-09-02

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