FDA 510(k) Application Details - K021981

Device Classification Name	Continuous, Ventilator, Home Use   More FDA Info for this Device
510(K) Number	K021981
Device Name	Continuous, Ventilator, Home Use
Applicant	VERSAMED LTD. P.O.B. 5011, ORNAT BLDG. HASHRON INDUSTRIAL PARK KADIMA 60920 IL Other 510(k) Applications for this Company
Contact	KEN RAICHMAN Other 510(k) Applications for this Contact
Regulation Number	868.5895   More FDA Info for this Regulation Number
Classification Product Code	NOU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/17/2002
Decision Date	08/13/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review