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GYE — Encephalogram Telemetry System Class II

FDA Device Classification

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-NumberApplicantDevice NameDate
K963195cme telemetrixWIRELESS EEG RECORDING SYSTEM MODEL W32July 29, 1997
K970659telediagnostic systemsDT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVERMay 16, 1997
K895895mennen medicalMODEL 219 TELEMETRY SYSTEMFebruary 22, 1990
K891405buckman coBMS-2000 MOBILE EEG SYSTEMAugust 2, 1989
K885328telediagnostic systemsRS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVERMarch 22, 1989
K883947telediagnostic systemsISO-100 ISOLATION AMPLIFIERDecember 5, 1988
K883461biohmDAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIESNovember 30, 1988
K874257telediagnostic systemsS-10 TELEPHONIC POLYSOMNOGRAPHDecember 11, 1987
K871120telediagnostic systemsM10 EEG MONITOR SCOPEMay 1, 1987
K860128grass-telefactor product groupMODAC-XXXX INTENSIVE MONITORING OF EEGMarch 27, 1986
K833236pharmaquestTELEPHONE TRANSMITTER T-10 EEGNovember 29, 1983
K833880pharmaquestTELEPHONIC RECEIVER R-10 EEGNovember 29, 1983
K832304electro-bio-medical servicesBRAEGEN III 10-CHANNEL TRANSMITTER-August 31, 1983
K813010pharmaquestEEG TELEPHONE TRANSMITTER, MODEL #T-7November 16, 1981
K811093electro-bio-medical servicesBRAEGEN EEG TRANSMITTER/RECEIVER SYSMay 5, 1981
K802656telediagnostic systemsMODEL T-6 EEG TELEPHONE TRANSMITTERNovember 26, 1980
K802657telediagnostic systemsMODEL AFR EEG TELEPHONE RECEIVERNovember 12, 1980
K792371burdickTELEMETRY SYSTEM XMT-1 & REC-1January 31, 1980
K792380physio-controlCMS 6000January 4, 1980
K761259general electricG.E. TELEMETRY MONITORINGDecember 21, 1976