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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 K173226
Device Name CardiMax Electrocardiograph
Applicant
Fukuda Denshi USA, Inc.
17725-C NE 65th St.
Redmond,  WA  98052
Applicant Contact Doug Blakely
Correspondent
Fukuda Denshi USA, Inc.
17725-C NE 65th St.
Redmond,  WA  98052
Correspondent Contact Doug Blakely
Regulation Number870.2340
Classification Product Code
DPS  
Date Received10/03/2017
Decision Date 04/16/2018
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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