SentEP

System, Image Processing, Radiological

SentiAR, Inc

The following data is part of a premarket notification filed by Sentiar, Inc with the FDA for Sentep.

Pre-market Notification Details

Device IDK192890
510k NumberK192890
Device Name:SentEP
ClassificationSystem, Image Processing, Radiological
Applicant SentiAR, Inc 212 Kingshighway Blvd., Suite 115 Mailbox 28 St. Louis,  MO  63108
ContactBerk Tas
CorrespondentBerk Tas
SentiAR, Inc 212 Kingshighway Blvd., Suite 115 Mailbox 28 St. Louis,  MO  63108
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-10
Decision Date2020-09-18

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