FDA 510(k) Application Details - K071149

Device Classification Name	Ventilator, Non-Continuous (Respirator)   More FDA Info for this Device
510(K) Number	K071149
Device Name	Ventilator, Non-Continuous (Respirator)
Applicant	HANS RUDOLPH, INC. 7205 CENTRAL KANSAS CITY, MO 64114 US Other 510(k) Applications for this Company
Contact	KEVIN RUDOLPH 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	04/24/2007
Decision Date	02/01/2008
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