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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K875057
Device Name FUKUDA MODEL DS-503 DYNASCOPE PATIENT MONITOR
Applicant
Fukuda Denshi USA, Inc.
12539 130th Ln. Ne
Kirkland,  WA  98034
Applicant Contact ROBERT STEURER
Correspondent
Fukuda Denshi USA, Inc.
12539 130th Ln. Ne
Kirkland,  WA  98034
Correspondent Contact ROBERT STEURER
Regulation Number870.2340
Classification Product Code
DPS  
Date Received12/09/1987
Decision Date 03/22/1988
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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