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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K071960
Device Name MEDITECH AMBULATORY BLOOD PRESSURE MONITOR, MODEL ABPM-05
Applicant
Meditech Kft.
Industrial Park 13,
M.P. Misgav
Mitzpe Aviv,  IL 20187
Applicant Contact BENNY ARAZY
Correspondent
Meditech Kft.
Industrial Park 13,
M.P. Misgav
Mitzpe Aviv,  IL 20187
Correspondent Contact BENNY ARAZY
Regulation Number870.1130
Classification Product Code
DXN  
Date Received07/16/2007
Decision Date 08/03/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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