Atlas FDA

GYE

20 FDA 510(k) clearances · Product code

66 daysmedian time to decision
141 days90th percentile
20clearances measured

FDA profile

Official device name
Encephalogram Telemetry System
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1855
Medical specialty
Neurology
Adverse events (MAUDE)
1993: 2 · 1994: 3 · 1996: 1 · 1997: 3 · 2004: 2 · 2005: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
WIRELESS EEG RECORDING SYSTEM MODEL W32 (K963195)Cme Telemetrix, Inc.1997-07-29
DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER (K970659)Telediagnostic Systems, Inc.1997-05-16
MODEL 219 TELEMETRY SYSTEM (K895895)Mennen Medical, Inc.1990-02-22
BMS-2000 MOBILE EEG SYSTEM (K891405)Buckman Co., Inc.1989-08-02
RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER (K885328)Telediagnostic Systems, Inc.1989-03-22
ISO-100 ISOLATION AMPLIFIER (K883947)Telediagnostic Systems, Inc.1988-12-05
DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIES (K883461)Biohm, Inc.1988-11-30
S-10 TELEPHONIC POLYSOMNOGRAPH (K874257)Telediagnostic Systems, Inc.1987-12-11
M10 EEG MONITOR SCOPE (K871120)Telediagnostic Systems, Inc.1987-05-01
MODAC-XXXX INTENSIVE MONITORING OF EEG (K860128)Grass-Telefactor Product Group1986-03-27
TELEPHONIC RECEIVER R-10 EEG (K833880)Pharmaquest Corp.1983-11-29
TELEPHONE TRANSMITTER T-10 EEG (K833236)Pharmaquest Corp.1983-11-29
BRAEGEN III 10-CHANNEL TRANSMITTER- (K832304)Electro-Bio-Medical Services, Inc.1983-08-31
EEG TELEPHONE TRANSMITTER, MODEL #T-7 (K813010)Pharmaquest Corp.1981-11-16
BRAEGEN EEG TRANSMITTER/RECEIVER SYS (K811093)Electro-Bio-Medical Services, Inc.1981-05-05
MODEL T-6 EEG TELEPHONE TRANSMITTER (K802656)Telediagnostic Systems, Inc.1980-11-26
MODEL AFR EEG TELEPHONE RECEIVER (K802657)Telediagnostic Systems, Inc.1980-11-12
TELEMETRY SYSTEM XMT-1 & REC-1 (K792371)Burdick Corp.1980-01-31
CMS 6000 (K792380)Physio-Control Corp.1980-01-04
G.E. TELEMETRY MONITORING (K761259)General Electric Co.1976-12-21

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Every clearance here is in the API, with alerts when new ones post.