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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
510(k) Number K022914
Device Name RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES
Applicant
Rhythmlink International, LLC
2013 Windsor Dr.
Cayce,  SC  29033
Applicant Contact BRETT L NETHERTON
Correspondent
Rhythmlink International, LLC
2013 Windsor Dr.
Cayce,  SC  29033
Correspondent Contact BRETT L NETHERTON
Regulation Number882.1350
Classification Product Code
GXZ  
Date Received09/03/2002
Decision Date 12/20/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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