FDA 510(k) Application Details - K012825

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K012825
Device Name	Computer, Diagnostic, Programmable
Applicant	LEV-EL, LTD. MIZPE AVIV INDUSTRIAL PARK 13 M.P. MISGAV 20187 IL Other 510(k) Applications for this Company
Contact	EINAT SHAMMAI Other 510(k) Applications for this Contact
Regulation Number	870.1425   More FDA Info for this Regulation Number
Classification Product Code	DQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/23/2001
Decision Date	03/19/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review