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 |