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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 K090052
Device Name CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C
Applicant
JOHARI DIGITAL HEALTHCARE, LTD.
ELECTRONIC HARDWARE TECHNOLOGY
PARK, G-582, 583, E.P.I.P
BORANADA, JODHPUR, RAJASTHAN,  IN 342008
Applicant Contact NISHA JOHARI
Correspondent
JOHARI DIGITAL HEALTHCARE, LTD.
ELECTRONIC HARDWARE TECHNOLOGY
PARK, G-582, 583, E.P.I.P
BORANADA, JODHPUR, RAJASTHAN,  IN 342008
Correspondent Contact NISHA JOHARI
Regulation Number882.5800
Classification Product Code
QJQ  
Subsequent Product Code
GZJ  
Date Received01/07/2009
Decision Date 05/29/2009
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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