FDA product code GYE: Encephalogram Telemetry System
GYE is the FDA product code for encephalogram telemetry system. It is a Class II device, regulated under 21 CFR 882.1855 and reviewed by the Neurology panel. FDA has cleared 20 510(k) submissions under GYE, from 11 different applicants. The average 510(k) review took 76 days (median 59).
Classification
| Field | Value |
|---|---|
| Device name | Encephalogram Telemetry System |
| Device class | Class II |
| Regulation | 21 CFR 882.1855 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GYE clearance
Top GYE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Telediagnostic Systems, Inc. | 7 | 1997-05-16 |
| Pharmaquest Corp. | 3 | 1983-11-29 |
| Electro-Bio-Medical Services, Inc. | 2 | 1983-08-31 |
| Cme Telemetrix, Inc. | 1 | 1997-07-29 |
| Mennen Medical, Inc. | 1 | 1990-02-22 |
6 more applicants have GYE clearances. See the full list in Caduvo.
Most recent GYE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K963195 | Cme Telemetrix, Inc. | WIRELESS EEG RECORDING SYSTEM MODEL W32 | 1997-07-29 | 348 |
| K970659 | Telediagnostic Systems, Inc. | DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER | 1997-05-16 | 84 |
| K895895 | Mennen Medical, Inc. | MODEL 219 TELEMETRY SYSTEM | 1990-02-22 | 139 |
| K891405 | Buckman Co., Inc. | BMS-2000 MOBILE EEG SYSTEM | 1989-08-02 | 141 |
| K885328 | Telediagnostic Systems, Inc. | RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER | 1989-03-22 | 84 |
Recalls for GYE devices
openFDA lists no recalls for product code GYE.
Frequently asked questions
What is FDA product code GYE?
GYE is the FDA product code for encephalogram telemetry system. It is a Class II device, regulated under 21 CFR 882.1855 and reviewed by the Neurology panel.
What device class is GYE?
Class II, regulation 21 CFR 882.1855. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GYE?
Across 20 cleared submissions the average was 76 days from receipt to decision (median 59).
Which companies have the most GYE clearances?
Telediagnostic Systems, Inc. (7); Pharmaquest Corp. (3); Electro-Bio-Medical Services, Inc. (2); Cme Telemetrix, Inc. (1); Mennen Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code GYE
- Run a recall and safety report across every GYE manufacturer
- Watch product code GYE for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Neurology product codes · FDA product code lookup · 510(k) database search · 510(k) review times