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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
510(k) Number K062284
Device Name CES ULTRA
Applicant
Neuro-Fitness, LLC
P.O. Box 1031
Snoqualmie,  WA  98065
Applicant Contact MICHAEL STEVENS
Correspondent
Neuro-Fitness, LLC
P.O. Box 1031
Snoqualmie,  WA  98065
Correspondent Contact MICHAEL STEVENS
Regulation Number882.5800
Classification Product Code
QJQ  
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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