RetinAI Discovery

System, Image Management, Ophthalmic

RetinAI Medical AG

The following data is part of a premarket notification filed by Retinai Medical Ag with the FDA for Retinai Discovery.

Pre-market Notification Details

Device IDK211715
510k NumberK211715
Device Name:RetinAI Discovery
ClassificationSystem, Image Management, Ophthalmic
Applicant RetinAI Medical AG Freiburgstrasse, 3 Bern,  CH 3010
ContactEnisa Dresevic
CorrespondentEnisa Dresevic
RetinAI Medical AG Freiburgstrasse, 3 Bern,  CH 3010
Product CodeNFJ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-03
Decision Date2022-04-28

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