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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, cranial electrotherapy
510(k) Number K062284
Device Name CES ULTRA
Original Applicant
NEURO-FITNESS LLC
p.o. box 1031
snoqualmie,  WA  98065
Original Contact michael stevens
Regulation Number882.5800
Classification Product Code
JXK  
Date Received08/07/2006
Decision Date 04/05/2007
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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