The following data is part of a premarket notification filed by Pharmaquest Corp. with the FDA for Telephonic Receiver R-10 Eeg.
| Device ID | K833880 |
| 510k Number | K833880 |
| Device Name: | TELEPHONIC RECEIVER R-10 EEG |
| Classification | Encephalogram Telemetry System |
| Applicant | PHARMAQUEST CORP. 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 | 1983-11-16 |
| Decision Date | 1983-11-29 |