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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K003999
Device Name AVIVA SYSTEM, MODEL SL 2020; AVIVA SLX SYSTEM SYSTEM, MODEL SLX 1010
Applicant
AMERICAN TELECARE, INC.
7640 GOLDEN TRIANGLE DR.
EDEN PRAIRIE,  MN  55344 -3732
Applicant Contact CHARLES RICHARD ABBRUSCATO
Correspondent
AMERICAN TELECARE, INC.
7640 GOLDEN TRIANGLE DR.
EDEN PRAIRIE,  MN  55344 -3732
Correspondent Contact CHARLES RICHARD ABBRUSCATO
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
DRG   DXN  
Date Received12/26/2000
Decision Date 06/28/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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