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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dc-Defibrillator, Low-Energy, (Including Paddles)
510(k) Number K850618
Device Name FC-700 DEFIBRILLATOR
Applicant
Fukuda Denshi USA, Inc.
12539 130th Ln. Ne
Kirkland,  WA  98034
Applicant Contact DON ANDRESEN
Correspondent
Fukuda Denshi USA, Inc.
12539 130th Ln. Ne
Kirkland,  WA  98034
Correspondent Contact DON ANDRESEN
Regulation Number870.5300
Classification Product Code
LDD  
Date Received02/15/1985
Decision Date 04/19/1985
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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