Product code GYE— Neurology
BMS-2000 MOBILE EEG SYSTEM
- Classification name
- Encephalogram Telemetry System
- Device class
- Class 2
- Regulation
- 21 CFR 882.1855
- Advisory panel
- Neurology
- Total cleared
- 20
- First cleared
- Most recent
Market context for product code GYE
FDA has cleared devices under product code GYE between 1976 and 1997, filed by 11 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1997
- 1990
- 1989
- 1988
- 1987
- 1986
- 1983
- 1981
- 1980
- 1976
Top applicants under product code GYE
Recent clearances under product code GYE
- K963195 — WIRELESS EEG RECORDING SYSTEM MODEL W32
- K970659 — DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER
- K895895 — MODEL 219 TELEMETRY SYSTEM
- K891405 — BMS-2000 MOBILE EEG SYSTEM
- K885328 — RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER
- K883947 — ISO-100 ISOLATION AMPLIFIER
- K883461 — DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIES
- K874257 — S-10 TELEPHONIC POLYSOMNOGRAPH
- K871120 — M10 EEG MONITOR SCOPE
- K860128 — MODAC-XXXX INTENSIVE MONITORING OF EEG
- K833236 — TELEPHONE TRANSMITTER T-10 EEG
- K833880 — TELEPHONIC RECEIVER R-10 EEG
- K832304 — BRAEGEN III 10-CHANNEL TRANSMITTER-
- K813010 — EEG TELEPHONE TRANSMITTER, MODEL #T-7
- K811093 — BRAEGEN EEG TRANSMITTER/RECEIVER SYS
- K802656 — MODEL T-6 EEG TELEPHONE TRANSMITTER
- K802657 — MODEL AFR EEG TELEPHONE RECEIVER
- K792371 — TELEMETRY SYSTEM XMT-1 & REC-1
- K792380 — CMS 6000
- K761259 — G.E. TELEMETRY MONITORING
Data sourced from openFDA. This site is unofficial and independent of the FDA.