FDA 510(k) Application Details - K034053

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K034053
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	TIARA MEDICAL SYSTEMS, INC. 14414 DETROIT AVE, SUITE 205 LAKEWOOD, OH 44107 US Other 510(k) Applications for this Company
Contact	GEOFFREY SLEEPER 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	12/30/2003
Decision Date	06/24/2004
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