FDA 510(k) Application Details - K132516

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K132516
Device Name	Oximeter
Applicant	BIO MEDICAL TECHNOLOGIES CO., LTD P.O. BOX 560 STILLWATER, MN 55082 US Other 510(k) Applications for this Company
Contact	ELAINE DUNCAN 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	08/12/2013
Decision Date	07/30/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review