510(k) K761259
- Device
- G.E. TELEMETRY MONITORING
- Applicant
- General Electric Co.
- 510(k) number
- K761259
- Product code
- GYE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-12-21
- Date received
- 1976-12-15
- Regulation
- 882.1855
- Classification name
- Encephalogram Telemetry System
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GYE#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K963195 | WIRELESS EEG RECORDING SYSTEM MODEL W32 | Cme Telemetrix, Inc. | 1997-07-29 |
| K970659 | DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER | Telediagnostic Systems, Inc. | 1997-05-16 |
| K895895 | MODEL 219 TELEMETRY SYSTEM | Mennen Medical, Inc. | 1990-02-22 |
| K891405 | BMS-2000 MOBILE EEG SYSTEM | Buckman Co., Inc. | 1989-08-02 |
| K885328 | RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER | Telediagnostic Systems, Inc. | 1989-03-22 |
| K883947 | ISO-100 ISOLATION AMPLIFIER | Telediagnostic Systems, Inc. | 1988-12-05 |
| K883461 | DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIES | Biohm, Inc. | 1988-11-30 |
| K874257 | S-10 TELEPHONIC POLYSOMNOGRAPH | Telediagnostic Systems, Inc. | 1987-12-11 |
| K871120 | M10 EEG MONITOR SCOPE | Telediagnostic Systems, Inc. | 1987-05-01 |
| K860128 | MODAC-XXXX INTENSIVE MONITORING OF EEG | Grass-Telefactor Product Group | 1986-03-27 |
| K833880 | TELEPHONIC RECEIVER R-10 EEG | Pharmaquest Corp. | 1983-11-29 |
| K833236 | TELEPHONE TRANSMITTER T-10 EEG | Pharmaquest Corp. | 1983-11-29 |
| K832304 | BRAEGEN III 10-CHANNEL TRANSMITTER- | Electro-Bio-Medical Services, Inc. | 1983-08-31 |
| K813010 | EEG TELEPHONE TRANSMITTER, MODEL #T-7 | Pharmaquest Corp. | 1981-11-16 |
| K811093 | BRAEGEN EEG TRANSMITTER/RECEIVER SYS | Electro-Bio-Medical Services, Inc. | 1981-05-05 |