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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K083715
Device Name BELTBEAT WF-400
Applicant
Bonus Communicaciones Srl
Industrial Park 13
M.P. Misgav
Mizpe Aviv,  IL 20184
Applicant Contact BENNY ARAZY
Correspondent
Bonus Communicaciones Srl
Industrial Park 13
M.P. Misgav
Mizpe Aviv,  IL 20184
Correspondent Contact BENNY ARAZY
Regulation Number870.2340
Classification Product Code
DPS  
Subsequent Product Codes
DRG   DRT  
Date Received12/15/2008
Decision Date 09/15/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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