The following data is part of a premarket notification filed by Teca, Inc. with the FDA for Neurolab Ii.
| Device ID | K844481 |
| 510k Number | K844481 |
| Device Name: | NEUROLAB II |
| Classification | Analyzer, Spectrum, Electroencephalogram Signal |
| Applicant | TECA, INC. THREE CAMPUS DR. Pleasantiville, NY 10570 |
| Contact | Edward R Sirois |
| Correspondent | Edward R Sirois TECA, INC. THREE CAMPUS DR. Pleasantiville, NY 10570 |
| Product Code | GWS |
| CFR Regulation Number | 882.1420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-19 |
| Decision Date | 1985-05-20 |