FDA 510(k) Application Details - K143474

Device Classification Name	More FDA Info for this Device
510(K) Number	K143474
Device Name	Artemis Hand Held Imaging System
Applicant	QUEST MEDICAL IMAGING INDUSTRIEWEG 41 MIDDENMEER 1775 PW NL Other 510(k) Applications for this Company
Contact	MARTIN HEUVELMANS Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/05/2014
Decision Date	06/30/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review