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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 K964697
Device Name AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION
Applicant
Advance Medical Device, Inc.
152 W. Wisconsin Ave.
Milwaukee,  WI  53203
Applicant Contact BRIAN W PETERSEN
Correspondent
Advance Medical Device, Inc.
152 W. Wisconsin Ave.
Milwaukee,  WI  53203
Correspondent Contact BRIAN W PETERSEN
Regulation Number870.1130
Classification Product Code
DXN  
Date Received11/22/1996
Decision Date 02/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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