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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 K840258
Device Name TEC-3500 DEFIBRILLATOR
Applicant
Nihon Kohden America, Inc.
90 Icon St.
Foothill,  CA  92610
Correspondent
Nihon Kohden America, Inc.
90 Icon St.
Foothill,  CA  92610
Regulation Number870.5300
Classification Product Code
LDD  
Date Received01/23/1984
Decision Date 05/23/1984
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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