The following data is part of a premarket notification filed by Teca, Inc. with the FDA for Teca Neuromapper 1620, Brain Mapper.
| Device ID | K894088 |
| 510k Number | K894088 |
| Device Name: | TECA NEUROMAPPER 1620, BRAIN MAPPER |
| Classification | Non-normalizing Quantitative Electroencephalograph Software |
| Applicant | TECA, INC. THREE CAMPUS DR. Pleasantiville, NY 10570 |
| Contact | Scott A Grillo |
| Correspondent | Scott A Grillo TECA, INC. THREE CAMPUS DR. Pleasantiville, NY 10570 |
| Product Code | OLT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-08 |
| Decision Date | 1989-11-15 |