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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 K010029
Device Name HOME HEALTH MONITORING SYSTEM
Applicant
Avid Care Corp.
152 W. Wisconsin Ave.
Suite 930
Milwaukee,  WI  53203
Applicant Contact WILLIAM GENTHE
Correspondent
Avid Care Corp.
152 W. Wisconsin Ave.
Suite 930
Milwaukee,  WI  53203
Correspondent Contact WILLIAM GENTHE
Regulation Number870.1130
Classification Product Code
DXN  
Date Received01/03/2001
Decision Date 06/29/2001
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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