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510(k) K070412

ELEXOMA MEDIC by Redplane AG — Product Code QJQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2008
Date Received
February 12, 2007
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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