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510(k) K070412

Device
ELEXOMA MEDIC
Applicant
REDPLANE AG
510(k) number
K070412
Product code
JXK  
Decision
Substantially Equivalent (SESE)
Decision date
2008-05-21
Date received
2007-02-12
Regulation
882.5800
Classification name
Cranial Electrotherapy Stimulator To Treat Depression
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JAEN LABUSCHAGNE
Address
Baarerstrasse 8 Zug CH 6300 6300

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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