Del Mar Avionics
Medical device manufacturer in Irvine, CA.
54510(k) clearances
0PMA approvals
0recalls
Device types
- DSH Recorder, Magnetic Tape, Medical 15
- DSI Detector And Alarm, Arrhythmia 10
- GWQ Full-Montage Standard Electroencephalograph 7
- DPS Electrocardiograph 3
- DXN System, Measurement, Blood-Pressure… 2
- DXK Echocardiograph 2
- DXG Computer, Diagnostic, Pre-Programmed… 2
- DXH Transmitters And Receivers, Electrocardiogra… 1
- IOL Treadmill, Powered 1
- DRT Monitor, Cardiac (Incl. Cardiotachometer &… 1
- FFT Electrode, Ph, Stomach 1
- IKN Electromyograph, Diagnostic 1
- OLT Non-Normalizing Quantitative… 1
- DSF Recorder, Paper Chart 1
- DTC Analyzer, Pacemaker Generator Function 1
- DSK Computer, Blood-Pressure 1
- DRS Transducer, Blood-Pressure, Extravascular 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K990027 | Omnicorder, Model 464DSH · Abbreviated | 02/09/1999SE |
| K971696 | Sentinel Recorder, Models 471/472DXH · Traditional | 12/30/1997SE |
| K963174 | Holter Digicorder with Pacer Option (Model 483)DSH · Traditional | 03/13/1997SE |
| K950020 | Holter Pacercorder(R)DSH · Traditional | 08/17/1995SE |
| K942653 | Holter SSR Digicorder(Tm)DSH · Traditional | 05/10/1995SE |
| K922221 | Sprint DX, Model 5400 Exercise Stress Test SystemLOS · Traditional | 04/21/1993SE |
| K896862 | Model 263 Spectrascan(Tm) Holter Analysis SystemDSI · Traditional | 04/18/1990SE |
| K895793 | Micropotential Analyzer/Spectrocardiography OptionDSH · Traditional | 02/13/1990SE |
| K894543 | Model 493 SSR-3 Three Channel Solid-State RecorderDSI · Traditional | 02/08/1990SE |
| K891148 | Model 152 Delta Holter ECG Analysis SystemDSI · Traditional | 05/11/1989SE |
| K884887 | Model 499 SSR Analysis SystemDSI · Traditional | 02/06/1989SE |
| K884330 | Model 463 Electrocardiorecorder RecorderDSH · Traditional | 01/05/1989SE |
| K884009 | Model 459 Electrocardiocorder RecorderDSH · Traditional | 11/09/1988SE |
| K874313 | Model 492 SSR (TM) RecorderDSH · Traditional | 02/22/1988SE |
| K872658 | Model 980-CARDIOSCOPE AT-3 ElectrocardiographDPS · Traditional | 01/06/1988SE |
| K863387 | MultipleDXK · Traditional | 09/04/1987SE |
| K863652 | Model 456 Electrocardiorecorder RecorderDPS · Traditional | 12/10/1986SE |
| K860471 | Del Amr Model 250 Cardiodisplay Holter ScannerDSI · Traditional | 04/30/1986SE |
| K860470 | Del Mar Model 750 Innovator Holter Management SystDSI · Traditional | 04/30/1986SE |
| K854269 | Model 509A Physiocorder Ambulatory RecorderDSH · Traditional | 04/11/1986SE |
| K854268 | Del Mar Avionics 5509A Physioscanner EEG ScannerGWQ · Traditional | 03/27/1986SE |
| K844896 | Del Mar Avionics 8300 Sector Imager SysDXK · Traditional | 06/10/1985SE |
| K850044 | Treadmill E-17IOL · Traditional | 04/04/1985SE |
| K850043 | Cardioguard Stress Test Monitor 4002DRT · Traditional | 02/08/1985SE |
| K841654 | Del Mar Avionics 509 Neurocorder AmbulDSH · Traditional | 12/11/1984SE |
| K841653 | Del Mar Avionics 5509 Neuro-ScannerGWQ · Traditional | 12/03/1984SE |
| K840622 | Cardio Express 100 Holter ScannerDSI · Traditional | 07/02/1984SE |
| K833661 | Electrocardiocorder Recorder 453DSH · Traditional | 11/28/1983SE |
| K822815 | Model 700 Gastroreflux Monitor/AmalyzerFFT · Traditional | 10/22/1982SE |
| K822751 | Del Mar Avionics Model 551 Neurocorder · Traditional | 10/08/1982SE |
| K822624 | O.T.E. Biomedica B.A.S.I.S. Model 2381IKN · Traditional | 10/06/1982SE |
| K822700 | Del Mar Model 5500 EEG ScannerGWQ · Traditional | 10/04/1982SE |
| K820653 | Ote Biomedica Berg Fourier AnalyzerOLT · Traditional | 05/07/1982SE |
| K820779 | Ote Biomedical #1296 - 16 Chan. RecordGWQ · Traditional | 04/26/1982SE |
| K820605 | Ote Biomedica Neurograph 18GWQ · Traditional | 03/23/1982SE |
| K820604 | Ote Biomedica Neurograph 9GWQ · Traditional | 03/23/1982SE |
| K820603 | Ote Biomedica Neurograph 14GWQ · Traditional | 03/23/1982SE |
| K813222 | Model 4200 Ellestad Stress Test AnalyzerDXG · Traditional | 12/29/1981SE |
| K811122 | Del Mar Avionics Models 9400 & 9401DSI · Traditional | 06/12/1981SE |
| K801831 | Evaluator #9500 Dynamic Elec/ScannerDSI · Traditional | 09/09/1980SE |
| K801832 | Model 9200 Vis-U-ScanDSH · Traditional | 08/27/1980SE |
| K801830 | Model 9300 ElectrocardiovalidatorDSF · Traditional | 08/27/1980SE |
| K792079 | Model 447 ElectrocardiocorderDSH · Traditional | 12/27/1979SE |
| K792078 | Model 449 ElectrocardiocorderDSH · Traditional | 12/27/1979SE |
| K792076 | Model 448 PacercorderDSH · Traditional | 12/27/1979SE |
| K792074 | Model 674 Pacer AnalyzerDTC · Traditional | 12/27/1979SE |
| K792080 | Model 656 Arrhythmia AnalyzerDXG · Traditional | 12/04/1979SE |
| K792077 | Model 1981 Pressurometer Data AnalysisDSK · Traditional | 12/04/1979SE |
| K792075 | Model 1978 Pressurometer III AmbulatoryDXN · Traditional | 12/04/1979SE |
| K792071 | DCG Data Terminal · Traditional | 12/04/1979SE |
| K792073 | Model 1979 Blood Pressurometer R CharterDRS · Traditional | 11/05/1979SE |
| K792072 | Model 685/686 Dynamic ELECTROCARDI0-DPS · Traditional | 11/05/1979SE |
| K791424 | Dcg-Vii ElectrocardioscannerDSI · Traditional | 08/28/1979SE |
| K771500 | Pressurometer IIDXN · Traditional | 08/16/1977SE |