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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K922394
Device Name CARDIOFAX Q ECG-8420A
Applicant
Nihon Kohden America, Inc.
2601 Campus Dr.
Irvine,  CA  92612
Applicant Contact PENNI PANNELL
Correspondent
Nihon Kohden America, Inc.
2601 Campus Dr.
Irvine,  CA  92612
Correspondent Contact PENNI PANNELL
Classification Product Code
LOS
Subsequent Product Code
MLD  
Date Received05/20/1992
Decision Date 03/01/1994
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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