Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1855](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1855) → GYE — Encephalogram Telemetry System # GYE · Encephalogram Telemetry System _Neurology · 21 CFR 882.1855 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYE ## Overview - **Product Code:** GYE - **Device Name:** Encephalogram Telemetry System - **Regulation:** [21 CFR 882.1855](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1855) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) ## Identification An electroencephalogram (EEG) telemetry system consists of transmitters, receivers, and other components used for remotely monitoring or measuring EEG signals by means of radio or telephone transmission systems. ## Classification Rationale Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9. ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9. ## Recent Cleared Devices (20 of 20) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K963195](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYE/K963195.md) | WIRELESS EEG RECORDING SYSTEM MODEL W32 | Cme Telemetrix, Inc. | Jul 29, 1997 | SESE | | [K970659](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYE/K970659.md) | DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER | Telediagnostic Systems, Inc. | May 16, 1997 | SESE | | [K895895](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYE/K895895.md) | MODEL 219 TELEMETRY SYSTEM | Mennen Medical, Inc. | Feb 22, 1990 | SESE | | [K891405](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYE/K891405.md) | BMS-2000 MOBILE EEG SYSTEM | Buckman Co., Inc. | Aug 2, 1989 | SESE | | [K885328](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYE/K885328.md) | RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER | Telediagnostic Systems, Inc. | Mar 22, 1989 | SESE | | [K883947](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYE/K883947.md) | ISO-100 ISOLATION AMPLIFIER | Telediagnostic Systems, Inc. | Dec 5, 1988 | SESE | | [K883461](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYE/K883461.md) | DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIES | Biohm, Inc. | Nov 30, 1988 | SESE | | [K874257](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYE/K874257.md) | S-10 TELEPHONIC POLYSOMNOGRAPH | Telediagnostic Systems, Inc. | Dec 11, 1987 | SESE | | [K871120](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYE/K871120.md) | M10 EEG MONITOR SCOPE | Telediagnostic Systems, Inc. | May 1, 1987 | SESE | | [K860128](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYE/K860128.md) | MODAC-XXXX INTENSIVE MONITORING OF EEG | Grass-Telefactor Product Group | Mar 27, 1986 | SESE | | [K833880](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYE/K833880.md) | TELEPHONIC RECEIVER R-10 EEG | Pharmaquest Corp. | Nov 29, 1983 | SESE | | [K833236](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYE/K833236.md) | TELEPHONE TRANSMITTER T-10 EEG | Pharmaquest Corp. | Nov 29, 1983 | SESE | | [K832304](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYE/K832304.md) | BRAEGEN III 10-CHANNEL TRANSMITTER- | Electro-Bio-Medical Services, Inc. | Aug 31, 1983 | SESE | | [K813010](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYE/K813010.md) | EEG TELEPHONE TRANSMITTER, MODEL #T-7 | Pharmaquest Corp. | Nov 16, 1981 | SESE | | [K811093](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYE/K811093.md) | BRAEGEN EEG TRANSMITTER/RECEIVER SYS | Electro-Bio-Medical Services, Inc. | May 5, 1981 | SESE | | [K802656](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYE/K802656.md) | MODEL T-6 EEG TELEPHONE TRANSMITTER | Telediagnostic Systems, Inc. | Nov 26, 1980 | SESE | | [K802657](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYE/K802657.md) | MODEL AFR EEG TELEPHONE RECEIVER | Telediagnostic Systems, Inc. | Nov 12, 1980 | SESE | | [K792371](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYE/K792371.md) | TELEMETRY SYSTEM XMT-1 & REC-1 | Burdick Corp. | Jan 31, 1980 | SESE | | [K792380](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYE/K792380.md) | CMS 6000 | Physio-Control Corp. | Jan 4, 1980 | SESE | | [K761259](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYE/K761259.md) | G.E. TELEMETRY MONITORING | General Electric Co. | Dec 21, 1976 | SESE | ## Top Applicants - Telediagnostic Systems, Inc. — 7 clearances - Pharmaquest Corp. — 3 clearances - Electro-Bio-Medical Services, Inc. — 2 clearances - Biohm, Inc. — 1 clearance - Buckman Co., Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYE](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYE) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com