FDA 510(k) Application Details - K012333

Device Classification Name	Oximeter, Ear   More FDA Info for this Device
510(K) Number	K012333
Device Name	Oximeter, Ear
Applicant	EPIC MEDICAL EQUIPMENT SERVICES, INC. 1800 10TH ST., SUITE 300 PLANO, TX 75074 US Other 510(k) Applications for this Company
Contact	KRISTA OAKES Other 510(k) Applications for this Contact
Regulation Number	870.2710   More FDA Info for this Regulation Number
Classification Product Code	DPZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/24/2001
Decision Date	10/17/2001
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