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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K893405
Device Name MODEL DS-504 DYNASCOPE PATIENT MONITOR
Applicant
Fukuda Denshi USA, Inc.
7102-A 180th Ave. Northeast
Redmond,  WA  98052
Applicant Contact ROBERT STEURER
Correspondent
Fukuda Denshi USA, Inc.
7102-A 180th Ave. Northeast
Redmond,  WA  98052
Correspondent Contact ROBERT STEURER
Regulation Number870.2300
Classification Product Code
DRT  
Date Received05/02/1989
Decision Date 10/02/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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