FDA 510(k) Application Details - K080348

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K080348
Device Name	Oximeter
Applicant	AIRSEP CORP. 401 CREEKSIDE DR. BUFFALO, NY 14228-2085 US Other 510(k) Applications for this Company
Contact	PETER WEISERBORN 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	02/11/2008
Decision Date	10/09/2008
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