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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 K051149
Device Name MEDITECH MODEL ABPM-04
Applicant
MEDITECH KFT.
INDUSTRIAL PARK 13
MIZPE AVIV
M.P. MISGAV,  IL 20187
Applicant Contact BENNY ARAZY
Correspondent
MEDITECH KFT.
INDUSTRIAL PARK 13
MIZPE AVIV
M.P. MISGAV,  IL 20187
Correspondent Contact BENNY ARAZY
Regulation Number870.1130
Classification Product Code
DXN  
Date Received05/04/2005
Decision Date 11/18/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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