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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrode, needle, diagnostic electromyograph
510(k) Number K854664
Device Name MEB-5200
Applicant
NIHON KOHDEN AMERICA, INC.
17112 ARMSTRONG AVE.
IRVINE,  CA  92714
Applicant Contact DIANA BEAL
Correspondent
NIHON KOHDEN AMERICA, INC.
17112 ARMSTRONG AVE.
IRVINE,  CA  92714
Correspondent Contact DIANA BEAL
Regulation Number890.1385
Classification Product Code
IKT  
Date Received11/20/1985
Decision Date 08/14/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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