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510(k) K090052

CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C by Johari Digital Healthcare , Ltd. — Product Code QJQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2009
Date Received
January 7, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety
Device Class
Class II
Regulation Number
882.5800
Review Panel
NE
Submission Type

To provide electrical current to the head to treat insomnia and/or anxiety

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