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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 K081891
Device Name FUKUDA DENSHI DYNASCOPE MODEL DS-7000/7000M PATIENT MONITOR
Applicant
Fukuda Denshi USA, Inc.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
Fukuda Denshi USA, Inc.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number870.1025
Classification Product Code
MHX  
Date Received07/02/2008
Decision Date 08/29/2008
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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