FDA 510(k) Application Details - K141164

Device Classification Name	Led Light Source   More FDA Info for this Device
510(K) Number	K141164
Device Name	Led Light Source
Applicant	QUEST MEDICAL IMAGING 526 S Main St Akron, OH 44311 US Other 510(k) Applications for this Company
Contact	MARTIN HEUVELMANS Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	NTN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/05/2014
Decision Date	03/16/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review