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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 K000746
Device Name FUKUDA DENSHI DYNASCOPE, MODEL DS-5800NX
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 Received03/08/2000
Decision Date 04/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
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