FDA 510(k) Application Details - K981668

Device Classification Name	Ventilator, Continuous, Facility Use   More FDA Info for this Device
510(K) Number	K981668
Device Name	Ventilator, Continuous, Facility Use
Applicant	VERSAMED LTD. 117 AHUZAH ST. RA'ANANNA 43373 IL Other 510(k) Applications for this Company
Contact	SHOSHANA FRIEDMAN 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	05/11/1998
Decision Date	04/07/1999
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