The following data is part of a premarket notification filed by Tracor Instruments, Inc. with the FDA for Response System, Tn-3000.
| Device ID | K781743 |
| 510k Number | K781743 |
| Device Name: | RESPONSE SYSTEM, TN-3000 |
| Classification | Amplifier, Physiological Signal |
| Applicant | TRACOR INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GWL |
| CFR Regulation Number | 882.1835 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-10-20 |
| Decision Date | 1978-12-01 |