Encephalogram Telemetry System
FDA product code GYE · Class II (moderate risk) · 21 CFR 882.1855 · Neurology
20510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K963195 | Wireless EEG Recording System Model W32GYE · Traditional | Cme Telemetrix, Inc. | 07/29/1997SE |
| K970659 | DT-24 Telephonic EEG TRANSMITTER/DR-24 Telephonic EEG ReceiverGYE · Traditional | Telediagnostic Systems, Inc. | 05/16/1997SE |
| K895895 | Model 219 Telemetry SystemGYE · Traditional | Mennen Medical, Inc. | 02/22/1990SE |
| K891405 | BMS-2000 Mobile EEG SystemGYE · Traditional | Buckman Co., Inc. | 08/02/1989SE |
| K885328 | RS-10 Telephonic Polysomnography ReceiverGYE · Traditional | Telediagnostic Systems, Inc. | 03/22/1989SE |
| K883947 | ISO-100 Isolation AmplifierGYE · Traditional | Telediagnostic Systems, Inc. | 12/05/1988SE |
| K883461 | Dad 16S, Data Acquistion Device 16 Ch. SeriesGYE · Traditional | Biohm, Inc. | 11/30/1988SE |
| K874257 | S-10 Telephonic PolysomnographGYE · Traditional | Telediagnostic Systems, Inc. | 12/11/1987SE |
| K871120 | M10 EEG Monitor ScopeGYE · Traditional | Telediagnostic Systems, Inc. | 05/01/1987SE |
| K860128 | Modac-Xxxx Intensive Monitoring of EEGGYE · Traditional | Grass-Telefactor Product Group | 03/27/1986SE |
| K833880 | Telephonic Receiver R-10 EEGGYE · Traditional | Pharmaquest Corp. | 11/29/1983SE |
| K833236 | Telephone Transmitter T-10 EEGGYE · Traditional | Pharmaquest Corp. | 11/29/1983SE |
| K832304 | Braegen III 10-CHANNEL Transmitter-GYE · Traditional | Electro-Bio-Medical Services, Inc. | 08/31/1983SE |
| K813010 | EEG Telephone Transmitter, Model #T-7GYE · Traditional | Pharmaquest Corp. | 11/16/1981SE |
| K811093 | Braegen EEG Transmitter/Receiver SysGYE · Traditional | Electro-Bio-Medical Services, Inc. | 05/05/1981SE |
| K802656 | Model T-6 EEG Telephone TransmitterGYE · Traditional | Telediagnostic Systems, Inc. | 11/26/1980SE |
| K802657 | Model Afr EEG Telephone ReceiverGYE · Traditional | Telediagnostic Systems, Inc. | 11/12/1980SE |
| K792371 | Telemetry System XMT-1 & REC-1GYE · Traditional | Burdick Corp. | 01/31/1980SE |
| K792380 | CMS 6000GYE · Traditional | Physio-Control Corp. | 01/04/1980SE |
| K761259 | G.E. Telemetry MonitoringGYE · Traditional | General Electric Co. | 12/21/1976SE |