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510(k) K895175

Device
NF-1 MINDPEACE
Applicant
NEUROFITNESS
510(k) number
K895175
Product code
JXK  
Decision
Substantially Equivalent (SESE)
Decision date
1989-11-08
Date received
1989-08-10
Regulation
882.5800
Classification name
Cranial Electrotherapy Stimulator To Treat Depression
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
CARL CHRISTINE
Address
14770 NE 95th St. Redmond WA US 98052 98052

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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