Product Code: GYE
FDA class 2
21 CFR 882.1855
Encephalogram Telemetry System
Neurology
The Encephalogram Telemetry System is a neurological monitoring device that wirelessly transmits EEG brain wave data from the patient to a remote recording station, enabling ambulatory or long-term monitoring of patients for seizure activity or other neurological events. It is classified as a Class 2 device (moderate risk). The product code is GYE under regulation 21 CFR 882.1855 in the Neurology specialty. No implant, life-sustaining, GMP exempt, or third-party review flags apply.
510(k)s
20
FEI Numbers
0
Registration Numbers
0
Unique Applicants
11
Years Active
21
Research product code GYE in seconds
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Basic Information
- Product Code
- GYE
- Device Class
- FDA class 2
- Regulation Number
- 882.1855
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 20 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K963195 | WIRELESS EEG RECORDING SYSTEM MODEL W32 | Jul 29, 1997 | Substantially Equivalent | Cme Telemetrix, Inc. |
| K970659 | DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER | May 16, 1997 | Substantially Equivalent | Telediagnostic Systems, Inc. |
| K895895 | MODEL 219 TELEMETRY SYSTEM | Feb 22, 1990 | Substantially Equivalent | Mennen Medical, Inc. |
| K891405 | BMS-2000 MOBILE EEG SYSTEM | Aug 02, 1989 | Substantially Equivalent | Buckman Co., Inc. |
| K885328 | RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER | Mar 22, 1989 | Substantially Equivalent | Telediagnostic Systems, Inc. |
| K883947 | ISO-100 ISOLATION AMPLIFIER | Dec 05, 1988 | Substantially Equivalent | Telediagnostic Systems, Inc. |
| K883461 | DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIES | Nov 30, 1988 | Substantially Equivalent | Biohm, Inc. |
| K874257 | S-10 TELEPHONIC POLYSOMNOGRAPH | Dec 11, 1987 | Substantially Equivalent | Telediagnostic Systems, Inc. |
| K871120 | M10 EEG MONITOR SCOPE | May 01, 1987 | Substantially Equivalent | Telediagnostic Systems, Inc. |
| K860128 | MODAC-XXXX INTENSIVE MONITORING OF EEG | Mar 27, 1986 | Substantially Equivalent | Grass-Telefactor Product Group |
| K833880 | TELEPHONIC RECEIVER R-10 EEG | Nov 29, 1983 | Substantially Equivalent | Pharmaquest Corp. |
| K833236 | TELEPHONE TRANSMITTER T-10 EEG | Nov 29, 1983 | Substantially Equivalent | Pharmaquest Corp. |
| K832304 | BRAEGEN III 10-CHANNEL TRANSMITTER- | Aug 31, 1983 | Substantially Equivalent | Electro-Bio-Medical Services, Inc. |
| K813010 | EEG TELEPHONE TRANSMITTER, MODEL #T-7 | Nov 16, 1981 | Substantially Equivalent | Pharmaquest Corp. |
| K811093 | BRAEGEN EEG TRANSMITTER/RECEIVER SYS | May 05, 1981 | Substantially Equivalent | Electro-Bio-Medical Services, Inc. |
| K802656 | MODEL T-6 EEG TELEPHONE TRANSMITTER | Nov 26, 1980 | Substantially Equivalent | Telediagnostic Systems, Inc. |
| K802657 | MODEL AFR EEG TELEPHONE RECEIVER | Nov 12, 1980 | Substantially Equivalent | Telediagnostic Systems, Inc. |
| K792371 | TELEMETRY SYSTEM XMT-1 & REC-1 | Jan 31, 1980 | Substantially Equivalent | Burdick Corp. |
| K792380 | CMS 6000 | Jan 04, 1980 | Substantially Equivalent | Physio-Control Corp. |
| K761259 | G.E. TELEMETRY MONITORING | Dec 21, 1976 | Substantially Equivalent | General Electric Co. |