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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K981066
Device Name FUKUDA DENSHI: CARDIOMAX, MODEL FX-4010 MULTI CHANNEL ELECTROCARDIOGRAPH
Applicant
Fukuda Denshi USA, Inc.
17725 NE 65th St.
Bldg. C
Redmond,  WA  98052 -4911
Applicant Contact DAVID J GERAGHTY
Correspondent
Fukuda Denshi USA, Inc.
17725 NE 65th St.
Bldg. C
Redmond,  WA  98052 -4911
Correspondent Contact DAVID J GERAGHTY
Classification Product Code
LOS
Date Received03/24/1998
Decision Date 08/31/1998
Decision Substantially Equivalent (SESE)
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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