FDA 510(k) Application Details - K943207

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K943207
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	AIRSEP CORP. 290 CREEKSIDE DR. BUFFALO, NY 14228 US Other 510(k) Applications for this Company
Contact	EDWARD E VRANA Other 510(k) Applications for this Contact
Regulation Number	868.5905   More FDA Info for this Regulation Number
Classification Product Code	BZD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/05/1994
Decision Date	07/29/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review