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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(with arrhythmia detection or alarms)
510(k) Number K134046
Device Name FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR
Applicant
FUKUDA DENSHI USA, INC.
17725 N.E. 65TH ST., BLDG. C
REDMOND,  WA  98052 -4911
Applicant Contact DOUG BLAKELY
Correspondent
FUKUDA DENSHI USA, INC.
17725 N.E. 65TH ST., BLDG. C
REDMOND,  WA  98052 -4911
Correspondent Contact DOUG BLAKELY
Regulation Number870.1025
Classification Product Code
MHX  
Date Received12/31/2013
Decision Date 02/12/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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