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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Pre-Programmed, Single-Function
510(k) Number K042144
Device Name NICOM
Applicant
Cheetah Medical, Inc.
Mizpe Aviv
Industrial Park 13
M.P. Misgav,  IL 20187
Applicant Contact BENNY ARAZY
Correspondent
Cheetah Medical, Inc.
Mizpe Aviv
Industrial Park 13
M.P. Misgav,  IL 20187
Correspondent Contact BENNY ARAZY
Regulation Number870.1435
Classification Product Code
DXG  
Date Received08/09/2004
Decision Date 11/12/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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