FDA 510(k) Application Details - K964092

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K964092
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	TIARA MEDICAL SYSTEMS, INC. 4220 W. 166TH ST. OAK FORREST, IL 60452 US Other 510(k) Applications for this Company
Contact	NORBERT E CICHON 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	10/11/1996
Decision Date	07/31/1997
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