FDA 510(k) Application Details - K022679

Device Classification Name	Ventilator, Continuous, Facility Use   More FDA Info for this Device
510(K) Number	K022679
Device Name	Ventilator, Continuous, Facility Use
Applicant	HAMILTON MEDICAL AG P.O. BOX 30008 (89520) 4990 ENERGY WAY RENO, NV 89502 US Other 510(k) Applications for this Company
Contact	DAVID THOMPSON 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	08/12/2002
Decision Date	10/22/2003
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