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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K910109
Device Name CARDIOSWISS CM-8
Applicant
Care Systems, Inc.
8300 Whitesburg Dr.
Huntsville,  AL  35802 -3008
Applicant Contact STEVE HARLESS
Correspondent
Care Systems, Inc.
8300 Whitesburg Dr.
Huntsville,  AL  35802 -3008
Correspondent Contact STEVE HARLESS
Regulation Number870.1025
Classification Product Code
DSI  
Date Received01/10/1991
Decision Date 09/23/1991
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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