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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 K971131
Device Name FUKUDA DENSHI MODEL DS-5100E PORTABLE PATIENT MONITOR
Applicant
FUKUDA DENSHI USA, INC.
17725 N.E. 65TH ST., BLDG. C
REDMOND,  WA  98052 -4911
Applicant Contact DAVID J GERAGHTY
Correspondent
FUKUDA DENSHI USA, INC.
17725 N.E. 65TH ST., BLDG. C
REDMOND,  WA  98052 -4911
Correspondent Contact DAVID J GERAGHTY
Regulation Number870.1025
Classification Product Code
DSI  
Date Received03/27/1997
Decision Date 10/03/1997
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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