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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 K971194
Device Name NIHON KOHDEN TEC-6100A CARDIOLIFE MINI DEFIBRILLATOR & ACCESSORIES
Applicant
Nihon Kohden America, Inc.
2601 Campus Dr.
Irvine,  CA  92612 -1601
Applicant Contact GARY REASONER
Correspondent
Nihon Kohden America, Inc.
2601 Campus Dr.
Irvine,  CA  92612 -1601
Correspondent Contact GARY REASONER
Regulation Number870.5300
Classification Product Code
LDD  
Date Received04/01/1997
Decision Date 07/09/1997
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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