RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES


Device Classification Name

electrode, needle

510(k) Number K022914
Device Name RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES
Original Applicant
RHYTHMLINK INTERNATIONAL, LLC
2013 windsor dr.
cayce, 
SC 
29033

Original Contact brett l netherton
Regulation Number 882.1350
Classification Product Code
GXZ  
Date Received 09/03/2002
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