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FDA 510(k) Application Details - K090052
Device Classification Name
More FDA Info for this Device
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 342008 IN
Other 510(k) Applications for this Company
Contact
NISHA JOHARI
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QJQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/07/2009
Decision Date
05/29/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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