GYEClass II
Encephalogram Telemetry System
Neurology · 21 CFR 882.1855
MDR events22All time
Recalls0All time
Registered firms0Currently listed
510(k) clearances20All time
Recent MDR events
22 adverse event reports on file
- CPR4May 7, 2025MalfunctionMicroport Crm S.r.l.1000165971-2025-00332
- CPR4Feb 11, 2025MalfunctionMicroport Crm S.r.l.1000165971-2025-00088
- APEXPRO TELEMETRY SYSTEMAug 20, 2010MalfunctionGe Healthcare2124823-2010-00085
- NIHON KOHDENAug 17, 2009Injury*MW5012480
- DATASCOPEJun 10, 2005OtherDatascope Corporation617280
- DATASCOPEJun 2, 2005MalfunctionDatascope Corp.611115
- PHILLIPS MEDICALMay 17, 2004DeathPhillips Medical Systems525741
- TELEMETRY MONITORING EQUIPMENT AND SOFTWAREMar 2, 2004DeathGeneral Electric Medical Systems513624
- NPB N-7500Sep 5, 1997MalfunctionNellcor Puritan Bennett2025525-1997-00023
- PROPAQ CORDLESSJun 16, 1997OtherProtocol Systems, Inc.3023750-1997-00001
Event type breakdown
Malfunction12
Death5
Injury3
Other2
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
20 clearances for this product code
- Cme Telemetrix, Inc.Jul 29, 1997
K963195 · WIRELESS EEG RECORDING SYSTEM MODEL W32
- Telediagnostic Systems, Inc.May 16, 1997
K970659 · DT-24 TELEPHONIC EEG TRANSMITTER/DR-24 TELEPHONIC EEG RECEIVER
- Mennen Medical, Inc.Feb 22, 1990
K895895 · MODEL 219 TELEMETRY SYSTEM
- Buckman Co., Inc.Aug 2, 1989
K891405 · BMS-2000 MOBILE EEG SYSTEM
- Telediagnostic Systems, Inc.Mar 22, 1989
K885328 · RS-10 TELEPHONIC POLYSOMNOGRAPHY RECEIVER
- Telediagnostic Systems, Inc.Dec 5, 1988
K883947 · ISO-100 ISOLATION AMPLIFIER
- Biohm, Inc.Nov 30, 1988
K883461 · DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIES
- Telediagnostic Systems, Inc.Dec 11, 1987
K874257 · S-10 TELEPHONIC POLYSOMNOGRAPH