The following data is part of a premarket notification filed by Electro-bio-medical Services, Inc. with the FDA for Braegen Eeg Transmitter/receiver Sys.
| Device ID | K811093 |
| 510k Number | K811093 |
| Device Name: | BRAEGEN EEG TRANSMITTER/RECEIVER SYS |
| Classification | Encephalogram Telemetry System |
| Applicant | ELECTRO-BIO-MEDICAL SERVICES, 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 | 1981-04-21 |
| Decision Date | 1981-05-05 |