FDA Product Code
FDA Product Code GYE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1855
510(k) Clearances — 20 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K963195 | WIRELESS EEG RECORDING SYSTEM MODEL W32 | Cme Telemetrix, Inc. | 1997-07-29 | Traditional | PDF ↗ |
| K970659 | DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER | Telediagnostic Systems, Inc. | 1997-05-16 | Traditional | PDF ↗ |
| K895895 | MODEL 219 TELEMETRY SYSTEM | Mennen Medical, Inc. | 1990-02-22 | Traditional | PDF ↗ |
| K891405 | BMS-2000 MOBILE EEG SYSTEM | Buckman Co., Inc. | 1989-08-02 | Traditional | PDF ↗ |
| K885328 | RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER | Telediagnostic Systems, Inc. | 1989-03-22 | Traditional | PDF ↗ |
| K883947 | ISO-100 ISOLATION AMPLIFIER | Telediagnostic Systems, Inc. | 1988-12-05 | Traditional | PDF ↗ |
| K883461 | DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIES | Biohm, Inc. | 1988-11-30 | Traditional | PDF ↗ |
| K874257 | S-10 TELEPHONIC POLYSOMNOGRAPH | Telediagnostic Systems, Inc. | 1987-12-11 | Traditional | PDF ↗ |
| K871120 | M10 EEG MONITOR SCOPE | Telediagnostic Systems, Inc. | 1987-05-01 | Traditional | PDF ↗ |
| K860128 | MODAC-XXXX INTENSIVE MONITORING OF EEG | Grass-Telefactor Product Group | 1986-03-27 | Traditional | PDF ↗ |
| K833236 | TELEPHONE TRANSMITTER T-10 EEG | Pharmaquest Corp. | 1983-11-29 | Traditional | PDF ↗ |
| K833880 | TELEPHONIC RECEIVER R-10 EEG | Pharmaquest Corp. | 1983-11-29 | Traditional | PDF ↗ |
| K832304 | BRAEGEN III 10-CHANNEL TRANSMITTER- | Electro-Bio-Medical Services, Inc. | 1983-08-31 | Traditional | PDF ↗ |
| K813010 | EEG TELEPHONE TRANSMITTER, MODEL #T-7 | Pharmaquest Corp. | 1981-11-16 | Traditional | PDF ↗ |
| K811093 | BRAEGEN EEG TRANSMITTER/RECEIVER SYS | Electro-Bio-Medical Services, Inc. | 1981-05-05 | Traditional | PDF ↗ |
| K802656 | MODEL T-6 EEG TELEPHONE TRANSMITTER | Telediagnostic Systems, Inc. | 1980-11-26 | Traditional | PDF ↗ |
| K802657 | MODEL AFR EEG TELEPHONE RECEIVER | Telediagnostic Systems, Inc. | 1980-11-12 | Traditional | PDF ↗ |
| K792371 | TELEMETRY SYSTEM XMT-1 & REC-1 | Burdick Corp. | 1980-01-31 | Traditional | PDF ↗ |
| K792380 | CMS 6000 | Physio-Control Corp. | 1980-01-04 | Traditional | PDF ↗ |
| K761259 | G.E. TELEMETRY MONITORING | General Electric Co. | 1976-12-21 | Traditional | PDF ↗ |
Product code GYE · Class II · Neurology. Data: openFDA.