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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 K971436
Device Name NIHON KOHDEN TEC-7511A/TEC-7521A CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES
Applicant
Nihon Kohden America, Inc.
2601 Campus Dr.
Irvine,  CA  92612
Applicant Contact GARY REASONER
Correspondent
Nihon Kohden America, Inc.
2601 Campus Dr.
Irvine,  CA  92612
Correspondent Contact GARY REASONER
Regulation Number870.5300
Classification Product Code
LDD  
Date Received04/18/1997
Decision Date 10/21/1997
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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