FDA 510(k) Application Details - K965172

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K965172
Device Name	Oximeter
Applicant	EPIC MEDICAL EQUIPMENT SERVICES, INC. 4643 WESTGROVE DALLAS, TX 75248 US Other 510(k) Applications for this Company
Contact	JEFFREY SECUNDA 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	12/24/1996
Decision Date	07/16/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review