FDA 510(k) Application Details - K962865

Device Classification Name	Monitor, Apnea, Facility Use   More FDA Info for this Device
510(K) Number	K962865
Device Name	Monitor, Apnea, Facility Use
Applicant	AIRSEP CORP. 290 CREEKSIDE DR. BUFFALO, NY 14228 US Other 510(k) Applications for this Company
Contact	RAVI K BANSAL Other 510(k) Applications for this Contact
Regulation Number	868.2377   More FDA Info for this Regulation Number
Classification Product Code	FLS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/23/1996
Decision Date	10/25/1996
Decision	ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review