Encephalogram Telemetry System

Product Code: GYE

Neurology Microwave Medical Products

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 882.1855


Radiation TypeMicrowave EMF
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as GYE

3678Encephalogram Telemetry SystemElectroencephalogram (EEG) Telemetry System.

Total Product Life Cycle (TPLC) Devices

3678Encephalogram Telemetry SystemElectroencephalogram (EEG) Telemetry System.

Pre-market Notifications for GYE

K970659DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVERTELEDIAGNOSTIC SYSTEMS, INC.
K963195WIRELESS EEG RECORDING SYSTEM MODEL W32CME TELEMETRIX, INC.
K895895MODEL 219 TELEMETRY SYSTEMMENNEN MEDICAL, INC.
K891405BMS-2000 MOBILE EEG SYSTEMBUCKMAN CO., INC.
K885328RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVERTELEDIAGNOSTIC SYSTEMS, INC.
K883947ISO-100 ISOLATION AMPLIFIERTELEDIAGNOSTIC SYSTEMS, INC.
K883461DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIESBIOHM, INC.
K874257S-10 TELEPHONIC POLYSOMNOGRAPHTELEDIAGNOSTIC SYSTEMS, INC.
K871120M10 EEG MONITOR SCOPETELEDIAGNOSTIC SYSTEMS, INC.
K860128MODAC-XXXX INTENSIVE MONITORING OF EEGGRASS-TELEFACTOR PRODUCT GROUP
K833880TELEPHONIC RECEIVER R-10 EEGPHARMAQUEST CORP.
K833236TELEPHONE TRANSMITTER T-10 EEGPHARMAQUEST CORP.
K832304BRAEGEN III 10-CHANNEL TRANSMITTER-ELECTRO-BIO-MEDICAL SERVICES, INC.
K813010EEG TELEPHONE TRANSMITTER, MODEL #T-7PHARMAQUEST CORP.
K811093BRAEGEN EEG TRANSMITTER/RECEIVER SYSELECTRO-BIO-MEDICAL SERVICES, INC.

Maude Adverse Events

APEXPRO TELEMETRY SYSTEMGE HEALTHCARE2010-08-20
NIHON KOHDEN*2009-08-17
DATASCOPEDATASCOPE CORPORATION2005-06-10
DATASCOPEDATASCOPE CORPORATION2005-06-10
DATASCOPEDATASCOPE CORP.2005-06-02
PHILLIPS MEDICALPHILLIPS MEDICAL SYSTEMS2004-05-17
TELEMETRY MONITORING EQUIPMENT AND SOFTWAREGENERAL ELECTRIC MEDICAL SYSTEMS2004-03-02
NPB N-7500NELLCOR PURITAN BENNETT1997-09-05
PROPAQ CORDLESSPROTOCOL SYSTEMS, INC.1997-06-16
NELLCOR PURITAN BENNETTPURITAN-BENNETT CORP.1997-05-14
PROPAQ CORDLESSPROTOCOL SYSTEMS, INC.1996-10-30
WANDER GUARDWANDERGUARD, INC.1994-09-15
TELEMETRY MONITORING EQUIPMENTMARQUETTE ELECTRONICS1994-07-29
DYNA-TEL 820DYNAMIC OPTIONS1994-07-28
TELECTRONICSTELECTRONIC, INC.1993-02-02
MARQUETTEMARQUETTE ELECTRONICS, INC.1993-01-04
MARQUETTEMARQUETTE ELECTRONICS1992-11-20
MARQUETTE 7500 SERIESMARQUETTE ELECTRONICS1992-10-05
ELECTROPHYSIOLOGICAL MACHINENICOLET1992-07-27
MARQUETTEMARQUETTE MEDICAL ELECTRONICS, INC.1992-05-12
MARQUETTEMARQUETTE ELECTRONICS, INC.1992-01-21

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