GYE · Encephalogram Telemetry System
Neurology · 21 CFR 882.1855 · Class 2
Overview
| Product Code | GYE |
|---|---|
| Device Name | Encephalogram Telemetry System |
| Regulation | 21 CFR 882.1855 |
| Device Class | Class 2 |
| Review Panel | Neurology |
Identification
An electroencephalogram (EEG) telemetry system consists of transmitters, receivers, and other components used for remotely monitoring or measuring EEG signals by means of radio or telephone transmission systems.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.
Recent Cleared Devices (20 of 20)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K963195 | WIRELESS EEG RECORDING SYSTEM MODEL W32 | Cme Telemetrix, Inc. | Jul 29, 1997 | SESE |
| K970659 | DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER | Telediagnostic Systems, Inc. | May 16, 1997 | SESE |
| K895895 | MODEL 219 TELEMETRY SYSTEM | Mennen Medical, Inc. | Feb 22, 1990 | SESE |
| K891405 | BMS-2000 MOBILE EEG SYSTEM | Buckman Co., Inc. | Aug 2, 1989 | SESE |
| K885328 | RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER | Telediagnostic Systems, Inc. | Mar 22, 1989 | SESE |
| K883947 | ISO-100 ISOLATION AMPLIFIER | Telediagnostic Systems, Inc. | Dec 5, 1988 | SESE |
| K883461 | DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIES | Biohm, Inc. | Nov 30, 1988 | SESE |
| K874257 | S-10 TELEPHONIC POLYSOMNOGRAPH | Telediagnostic Systems, Inc. | Dec 11, 1987 | SESE |
| K871120 | M10 EEG MONITOR SCOPE | Telediagnostic Systems, Inc. | May 1, 1987 | SESE |
| K860128 | MODAC-XXXX INTENSIVE MONITORING OF EEG | Grass-Telefactor Product Group | Mar 27, 1986 | SESE |
| K833880 | TELEPHONIC RECEIVER R-10 EEG | Pharmaquest Corp. | Nov 29, 1983 | SESE |
| K833236 | TELEPHONE TRANSMITTER T-10 EEG | Pharmaquest Corp. | Nov 29, 1983 | SESE |
| K832304 | BRAEGEN III 10-CHANNEL TRANSMITTER- | Electro-Bio-Medical Services, Inc. | Aug 31, 1983 | SESE |
| K813010 | EEG TELEPHONE TRANSMITTER, MODEL #T-7 | Pharmaquest Corp. | Nov 16, 1981 | SESE |
| K811093 | BRAEGEN EEG TRANSMITTER/RECEIVER SYS | Electro-Bio-Medical Services, Inc. | May 5, 1981 | SESE |
| K802656 | MODEL T-6 EEG TELEPHONE TRANSMITTER | Telediagnostic Systems, Inc. | Nov 26, 1980 | SESE |
| K802657 | MODEL AFR EEG TELEPHONE RECEIVER | Telediagnostic Systems, Inc. | Nov 12, 1980 | SESE |
| K792371 | TELEMETRY SYSTEM XMT-1 & REC-1 | Burdick Corp. | Jan 31, 1980 | SESE |
| K792380 | CMS 6000 | Physio-Control Corp. | Jan 4, 1980 | SESE |
| K761259 | G.E. TELEMETRY MONITORING | General Electric Co. | Dec 21, 1976 | SESE |
Top Applicants
- Telediagnostic Systems, Inc. — 7 clearances
- Pharmaquest Corp. — 3 clearances
- Electro-Bio-Medical Services, Inc. — 2 clearances
- Biohm, Inc. — 1 clearance
- Buckman Co., Inc. — 1 clearance
