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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 (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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