The following data is part of a premarket notification filed by Telediagnostic Systems, Inc. with the FDA for Model Afr Eeg Telephone Receiver.
| Device ID | K802657 |
| 510k Number | K802657 |
| Device Name: | MODEL AFR EEG TELEPHONE RECEIVER |
| Classification | Encephalogram Telemetry System |
| Applicant | TELEDIAGNOSTIC SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GYE |
| CFR Regulation Number | 882.1855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-24 |
| Decision Date | 1980-11-12 |