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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 K915879
Device Name HL-300 RECEIVER MODULE
Applicant
Fukuda Denshi USA, Inc.
7102-A 180th Ave. Northeast
Redmond,  WA  98052
Applicant Contact ROBERT J STEURER
Correspondent
Fukuda Denshi USA, Inc.
7102-A 180th Ave. Northeast
Redmond,  WA  98052
Correspondent Contact ROBERT J STEURER
Regulation Number870.2340
Classification Product Code
DPS  
Date Received12/30/1991
Decision Date 01/27/1992
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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