FDA 510(k) Application Details - DEN170021

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN170021
Device Name	SEM Scanner (Model 200)
Applicant	Bruin Biometrics, LLC 10960 Wilshire Blvd, Suite 950 Los Angeles, CA 90024 US Other 510(k) Applications for this Company
Contact	Ya-Chen Tonar Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/03/2017
Decision Date	12/20/2018
Decision	DENG -
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review