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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 K150030
Device Name Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor
Applicant
Fukuda Denshi USA, Inc.
17725 NE 65th St., Bldg. C
Redmond,  WA  98052
Applicant Contact Doug Blakely
Correspondent
Fukuda Denshi USA, Inc.
17725 NE 65th St., Bldg. C
Redmond,  WA  98052
Correspondent Contact Doug Blakely
Regulation Number870.1025
Classification Product Code
MHX  
Date Received01/08/2015
Decision Date 03/16/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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