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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K990031
Device Name NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM 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
Classification Product Code
LOS
Date Received01/05/1999
Decision Date 04/16/1999
Decision Substantially Equivalent (SESE)
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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