GYE — Encephalogram Telemetry System Class II
FDA product code GYE covers "Encephalogram Telemetry System", a Class II medical device regulated under 21 CFR 882.1855. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GYE
- Device Class
- Class II
- Regulation Number
- 882.1855
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K963195 | cme telemetrix | WIRELESS EEG RECORDING SYSTEM MODEL W32 | July 29, 1997 |
| K970659 | telediagnostic systems | DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER | May 16, 1997 |
| K895895 | mennen medical | MODEL 219 TELEMETRY SYSTEM | February 22, 1990 |
| K891405 | buckman co | BMS-2000 MOBILE EEG SYSTEM | August 2, 1989 |
| K885328 | telediagnostic systems | RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER | March 22, 1989 |
| K883947 | telediagnostic systems | ISO-100 ISOLATION AMPLIFIER | December 5, 1988 |
| K883461 | biohm | DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIES | November 30, 1988 |
| K874257 | telediagnostic systems | S-10 TELEPHONIC POLYSOMNOGRAPH | December 11, 1987 |
| K871120 | telediagnostic systems | M10 EEG MONITOR SCOPE | May 1, 1987 |
| K860128 | grass-telefactor product group | MODAC-XXXX INTENSIVE MONITORING OF EEG | March 27, 1986 |
| K833236 | pharmaquest | TELEPHONE TRANSMITTER T-10 EEG | November 29, 1983 |
| K833880 | pharmaquest | TELEPHONIC RECEIVER R-10 EEG | November 29, 1983 |
| K832304 | electro-bio-medical services | BRAEGEN III 10-CHANNEL TRANSMITTER- | August 31, 1983 |
| K813010 | pharmaquest | EEG TELEPHONE TRANSMITTER, MODEL #T-7 | November 16, 1981 |
| K811093 | electro-bio-medical services | BRAEGEN EEG TRANSMITTER/RECEIVER SYS | May 5, 1981 |
| K802656 | telediagnostic systems | MODEL T-6 EEG TELEPHONE TRANSMITTER | November 26, 1980 |
| K802657 | telediagnostic systems | MODEL AFR EEG TELEPHONE RECEIVER | November 12, 1980 |
| K792371 | burdick | TELEMETRY SYSTEM XMT-1 & REC-1 | January 31, 1980 |
| K792380 | physio-control | CMS 6000 | January 4, 1980 |
| K761259 | general electric | G.E. TELEMETRY MONITORING | December 21, 1976 |