FDA 510(k) Application Details - K182242

Device Classification Name	More FDA Info for this Device
510(K) Number	K182242
Device Name	VO200 û NeurOs Cerebral Oximetry System
Applicant	Mespere LifeSciences Inc. 180 Frobisher Drive, Suite 1C Waterloo N2V 2A2 CA Other 510(k) Applications for this Company
Contact	Rebecca S. Li Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/20/2018
Decision Date	12/26/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review