LSN

System, X-ray, Tomography, Computed

Imaging Biometrics, LLC

The following data is part of a premarket notification filed by Imaging Biometrics, Llc with the FDA for Lsn.

Pre-market Notification Details

Device IDK201092
510k NumberK201092
Device Name:LSN
ClassificationSystem, X-ray, Tomography, Computed
Applicant Imaging Biometrics, LLC 13416 Watertown Plank Road, Suite 260 Elm Grove,  WI  53122
ContactTimothy Dondlinger
CorrespondentTimothy Dondlinger
Imaging Biometrics, LLC 13416 Watertown Plank Road, Suite 260 Elm Grove,  WI  53122
Product CodeJAK  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-23
Decision Date2020-10-29

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