SEM Scanner (Model 200)

Pressure Ulcer Management Tool

Bruin Biometrics, LLC

The following data is part of a De Novo classification by Bruin Biometrics, Llc with the FDA for Sem Scanner (model 200).

Pre-market Notification Details

DeNovo IDDEN170021
Device Name:SEM Scanner (Model 200)
ClassificationPressure Ulcer Management Tool
Applicant Bruin Biometrics, LLC 10960 Wilshire Blvd, Suite 950 Los Angeles,  CA  90024
ContactYa-chen Tonar
Product CodeQEF  
CFR Regulation Number876.2100 [🔎]
DecisionGranted (DENG)
501(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardGastroenterology/Urology
Classification AdvisoryGastroenterology/Urology
TypeDirect
Date Received2017-04-03
Decision Date2018-12-20
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

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