The following data is part of a premarket notification filed by Neurotek, Inc. with the FDA for Nti-1000.
Device ID | K894097 |
510k Number | K894097 |
Device Name: | NTI-1000 |
Classification | Cranial Electrotherapy Stimulator To Treat Depression |
Applicant | NEUROTEK, INC. 601 N. MURLEN, SUITE 16 Olathe, KS 66062 |
Contact | Ray B Smith |
Correspondent | Ray B Smith NEUROTEK, INC. 601 N. MURLEN, SUITE 16 Olathe, KS 66062 |
Product Code | JXK |
CFR Regulation Number | 882.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-06-09 |
Decision Date | 1989-09-25 |