The following data is part of a premarket notification filed by Teca, Inc. with the FDA for P460, Dg32 Electroencephalograph.
| Device ID | K896666 |
| 510k Number | K896666 |
| Device Name: | P460, DG32 ELECTROENCEPHALOGRAPH |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | TECA, INC. THREE CAMPUS DR. Pleasantiville, NY 10570 |
| Contact | Arthur Blumenfeld |
| Correspondent | Arthur Blumenfeld TECA, INC. THREE CAMPUS DR. Pleasantiville, NY 10570 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-27 |
| Decision Date | 1990-02-16 |