Device Classification Name	Ventilator, Continuous, Facility Use
510(k) Number	K112754
Device Name	IVENT101
Applicant	VERSAMED MEDICAL SYSTEMS LTD. HASHARON INDUSTRIAL PARK ORNAT BLDG. P.O. BOX 5011 KADIMA,  IL 60920
Applicant Contact	SHLOMI DELER
Correspondent	VERSAMED MEDICAL SYSTEMS LTD. HASHARON INDUSTRIAL PARK ORNAT BLDG. P.O. BOX 5011 KADIMA,  IL 60920
Correspondent Contact	SHLOMI DELER
Regulation Number	868.5895
Classification Product Code	CBK
Subsequent Product Code	NOU
Date Received	09/21/2011
Decision Date	06/15/2012
Decision	Substantially Equivalent (SESE)
Regulation Medical Specialty	Anesthesiology
510k Review Panel	Anesthesiology
Summary	Summary
Type	Traditional
Reviewed by Third Party	No
Combination Product	No