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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 K964235
Device Name ABPM MOBIL-O-GRAPH BLOOD PRESSURE MONITOR, MODEL ABP CONTROL
Applicant
Industrielle Entwicklung Medizintechnik Und Vertri
1151 Hope St.
Stamford,  CT  06907
Applicant Contact UWE KORTH
Correspondent
Industrielle Entwicklung Medizintechnik Und Vertri
1151 Hope St.
Stamford,  CT  06907
Correspondent Contact UWE KORTH
Regulation Number870.1130
Classification Product Code
DXN  
Date Received10/23/1996
Decision Date 03/02/1999
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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