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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K871944
Device Name FUTURECARE CARELYNK SYSTEM (ENTIRE SYSTEM)
Applicant
Futurecare Systems, Inc.
6470 Riverview Ter.
Findley,  MN  55432
Applicant Contact CONSTANCE G BUNDY
Correspondent
Futurecare Systems, Inc.
6470 Riverview Ter.
Findley,  MN  55432
Correspondent Contact CONSTANCE G BUNDY
Regulation Number870.2800
Classification Product Code
DSH  
Date Received05/19/1987
Decision Date 06/24/1987
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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