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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K860024
Device Name FUKUDA DENSHI CARDIMAX FCP-211
Applicant
Brentwood Instruments, Inc.
3425 Lomita Blvd.
Torrange,  CA  90505
Applicant Contact RICHARD ROSENTHAL
Correspondent
Brentwood Instruments, Inc.
3425 Lomita Blvd.
Torrange,  CA  90505
Correspondent Contact RICHARD ROSENTHAL
Regulation Number870.1025
Classification Product Code
DSI  
Date Received01/03/1986
Decision Date 03/31/1986
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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