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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency
510(k) Number K993550
Device Name AVIVA SYSTEM, MODEL SL1010
Applicant
American Telecare, Inc.
7640 Golden Triangle Dr.
Eden Prairie,  MN  55344 -3732
Applicant Contact CHARLES RICHARD ABRUSCATO
Correspondent
American Telecare, Inc.
7640 Golden Triangle Dr.
Eden Prairie,  MN  55344 -3732
Correspondent Contact CHARLES RICHARD ABRUSCATO
Regulation Number870.2910
Classification Product Code
DRG  
Date Received10/20/1999
Decision Date 01/13/2000
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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