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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 K880575
Device Name CARDIOLIFE TEC-7300 W/OPTIONAL ACCESSORIES
Applicant
Nihon Kohden America, Inc.
17112 Armstrong Ave.
Irvine,  CA  92714
Applicant Contact MIKE DASHEFSKY
Correspondent
Nihon Kohden America, Inc.
17112 Armstrong Ave.
Irvine,  CA  92714
Correspondent Contact MIKE DASHEFSKY
Regulation Number870.5300
Classification Product Code
LDD  
Date Received02/10/1988
Decision Date 08/02/1988
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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