NTI-1000

Cranial Electrotherapy Stimulator To Treat Depression

NEUROTEK, INC.

The following data is part of a premarket notification filed by Neurotek, Inc. with the FDA for Nti-1000.

Pre-market Notification Details

Device IDK894097
510k NumberK894097
Device Name:NTI-1000
ClassificationCranial Electrotherapy Stimulator To Treat Depression
Applicant NEUROTEK, INC. 601 N. MURLEN, SUITE 16 Olathe,  KS  66062
ContactRay B Smith
CorrespondentRay B Smith
NEUROTEK, INC. 601 N. MURLEN, SUITE 16 Olathe,  KS  66062
Product CodeJXK  
CFR Regulation Number882.5800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-06-09
Decision Date1989-09-25

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