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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 K952882
FOIA Releasable 510(k) K952882
Device Name PERSONAL TELEMEDICINE SYSTEM
Applicant
American Telecare, Inc.
7680 Golden Triangle Dr.
Eden Prairie,  MN  55344
Applicant Contact CHARLES R ABBRUSCATO
Correspondent
American Telecare, Inc.
7680 Golden Triangle Dr.
Eden Prairie,  MN  55344
Correspondent Contact CHARLES R ABBRUSCATO
Regulation Number870.1130
Classification Product Code
DXN  
Date Received06/23/1995
Decision Date 09/09/1996
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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