FDA 510(k) Application Details - K964019

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K964019
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	NELLCOR PURITAN BENNETT, INC. 10200 VALLEY VIEW RD. EDEN PRAIRIE, MN 55344 US Other 510(k) Applications for this Company
Contact	CHRIS HADLAND 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	10/07/1996
Decision Date	06/18/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review