Medical Device Manufacturer · US , Arleta , CA

Medical Data Electronics

27 submissions · 27 cleared · Since 1985
27
Total
27
Cleared
0
Denied

Medical Data Electronics — FDA 510(k) Submissions

Medical Data Electronics has submitted 27 FDA 510(k) premarket notifications since 1985, of which 27 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Oximeter, Transmitters And Receivers, Electrocardiograph, Telephone, Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm), Pacemaker, Cardiac, External Transcutaneous (non-invasive), Detector And Alarm, Arrhythmia . Use the specialty filter in the sidebar to narrow results.

27 devices
1–25 of 27
MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414
K014294 · DQA Oximeter · Anesthesiology
Jan 2002 28d
MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500
K012336 · DSI Detector And Alarm,... · Cardiovascular
Oct 2001 71d
ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413
K000660 · DRO Pacemaker, Cardiac,... · Cardiovascular
Mar 2000 29d
ESCORT 100/300 SERIES B (ESCORT II) PATIENT MONITOR
K992413 · DRT Monitor, Cardiac (incl.... · Cardiovascular
Aug 1999 30d
ESCORT II+ 400 SERIES (ESCORT PRISM) MONITOR
K992411 · DRT Monitor, Cardiac (incl.... · Cardiovascular
Aug 1999 29d
ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500
K982104 · MLD Monitor, St Segment With... · Cardiovascular
Nov 1998 163d
MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR
K970763 · DQA Oximeter · Anesthesiology
Jul 1997 133d
ESCORT II CLINICAL THERMOMETRY MODULE (CTM)
K970011 · FLL Continuous Measurement... · General Hospital
Jul 1997 188d
ESCORT LINK CENTRAL STATION MONITOR
K970012 · DSI Detector And Alarm,... · Cardiovascular
Jun 1997 175d
ESORT II + 400 SERIES MONITOR
K961138 · DRO Pacemaker, Cardiac,... · Cardiovascular
Dec 1996 264d
CARDIAC OUTPUT OPTION 39
K943256 · DXG Computer, Diagnostic,... · Cardiovascular
Dec 1994 162d
END TIDAL CO2 OPTION B
K930524 · CCK Analyzer, Gas,... · Anesthesiology
Feb 1994 370d
ESCORT 100/300 SERIES B PATIENT MONITORS
K930004 · DRT Monitor, Cardiac (incl.... · Cardiovascular
Jun 1993 170d
ESCORT-LINK ARRHYTHMIA OPTION 23L
K915153 · DSI Detector And Alarm,... · Cardiovascular
Apr 1992 165d
ESCORT 300A SERIES DEFIBRILLATOR/PACER OPTION
K914458 · LDD Dc-defibrillator,... · Cardiovascular
Dec 1991 63d
ESCORT 300 SERIES
K911665 · LDD Dc-defibrillator,... · Cardiovascular
Aug 1991 139d
ESCORT MODEL 400T TELEMETRY ECG MONITOR
K902254 · DXH Transmitters And... · Cardiovascular
Jul 1990 67d
ESCORT MODEL 300
K902060 · DQA Oximeter · Anesthesiology
Jun 1990 35d
ESCORT-LINK (MODEL E3200)
K901591 · DXH Transmitters And... · Cardiovascular
May 1990 40d
ESCORT NON-INVASIVE BLOOD PRESSURE OPTION
K896958 · DXN System, Measurement,... · Cardiovascular
Mar 1990 89d
ESCORT PULSE OXIMETRY OPTION
K892120 · DQA Oximeter · Anesthesiology
Sep 1989 179d
ESCORT NON-INVASIVE BLOOD PRESSURE OPTION
K884742 · DXN System, Measurement,... · Cardiovascular
Feb 1989 80d
ESCORT - PORTABLE PATIENT MONITOR
K881986 · DXH Transmitters And... · Cardiovascular
Jul 1988 61d
ESCORT PORTABLE PATIENT MONITOR
K872291 · DXO Transducer, Pressure,... · Cardiovascular
Sep 1987 101d
ESCORT ECG MONITOR SIEMENS SIRECUST 466
K854234 · DPS Electrocardiograph · Cardiovascular
Jan 1986 92d
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