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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Paper Chart
510(k) Number K843836
Device Name THERMAL GRAYSCALE RF-100
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 Number870.2810
Classification Product Code
DSF  
Date Received10/01/1984
Decision Date 10/19/1984
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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