FDA 510(k) Application Details - K030515

Device Classification Name	Ventilator, Continuous, Facility Use   More FDA Info for this Device
510(K) Number	K030515
Device Name	Ventilator, Continuous, Facility Use
Applicant	HANS RUDOLPH, INC. 7200 WYANDOTTE KANSAS CITY, MO 64114 US Other 510(k) Applications for this Company
Contact	KEVIN RUDOLPH Other 510(k) Applications for this Contact
Regulation Number	868.5895   More FDA Info for this Regulation Number
Classification Product Code	CBK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/19/2003
Decision Date	05/02/2003
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