FDA 510(k) Application Details - K142209

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K142209
Device Name	Oximeter
Applicant	ORSENSE LTD 17 Ha'Mefalsim St. Kiryat Arie Petah-Tikva 49003 IL Other 510(k) Applications for this Company
Contact	Aharon Weinstein Other 510(k) Applications for this Contact
Regulation Number	870.2700   More FDA Info for this Regulation Number
Classification Product Code	DQA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/11/2014
Decision Date	01/16/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review