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510(k) K894097

Device
NTI-1000
Applicant
NEUROTEK, INC.
510(k) number
K894097
Product code
JXK  
Decision
Substantially Equivalent (SESE)
Decision date
1989-09-25
Date received
1989-06-09
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
RAY B SMITH
Address
601 N. Murlen, Suite 16 Olathe KS US 66062 66062

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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