The following data is part of a premarket notification filed by Teca, Inc. with the FDA for Ee1114, 1118, 1121 Electro-encephalograph.
| Device ID | K903004 |
| 510k Number | K903004 |
| Device Name: | EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPH |
| 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 | 1990-07-09 |
| Decision Date | 1990-11-15 |