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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
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