Company ยท US
Del Mar Avionics
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 1999. Name variants (Inc, Corp, punctuation) are merged.
54510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | 15 |
| DSI | Detector And Alarm, Arrhythmia | 10 |
| GWQ | Full-Montage Standard Electroencephalograph | 7 |
| DPS | Electrocardiograph | 3 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 2 |
| DXK | Echocardiograph | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 |
| DSF | Recorder, Paper Chart | 1 |
| DSK | Computer, Blood-Pressure | 1 |
| DTC | Analyzer, Pacemaker Generator Function | 1 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 1 |
| FFT | Electrode, Ph, Stomach | 1 |
| IKN | Electromyograph, Diagnostic | 1 |
| IOL | Treadmill, Powered | 1 |
| LOS | 1 | |
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 9, 1999 | K990027 | OMNICORDER, MODEL 464 Del Mar Avionics | DSH |
| Dec 30, 1997 | K971696 | SENTINEL RECORDER, MODELS 471/472 Del Mar Avionics | DXH |
| Mar 13, 1997 | K963174 | HOLTER DIGICORDER WITH PACER OPTION (MODEL 483) Del Mar Avionics | DSH |
| Aug 17, 1995 | K950020 | HOLTER PACERCORDER(R) Del Mar Avionics | DSH |
| May 10, 1995 | K942653 | HOLTER SSR DIGICORDER(TM) Del Mar Avionics | DSH |
| Apr 21, 1993 | K922221 | SPRINT DX, MODEL 5400 EXERCISE STRESS TEST SYSTEM Del Mar Avionics | LOS |
| Apr 18, 1990 | K896862 | MODEL 263 SPECTRASCAN(TM) HOLTER ANALYSIS SYSTEM Del Mar Avionics | DSI |
| Feb 13, 1990 | K895793 | MICROPOTENTIAL ANALYZER/SPECTROCARDIOGRAPHY OPTION Del Mar Avionics | DSH |
| Feb 8, 1990 | K894543 | MODEL 493 SSR-3 THREE CHANNEL SOLID-STATE RECORDER Del Mar Avionics | DSI |
| May 11, 1989 | K891148 | MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM Del Mar Avionics | DSI |
| Feb 6, 1989 | K884887 | MODEL 499 SSR ANALYSIS SYSTEM Del Mar Avionics | DSI |
| Jan 5, 1989 | K884330 | MODEL 463 ELECTROCARDIORECORDER RECORDER Del Mar Avionics | DSH |
| Nov 9, 1988 | K884009 | MODEL 459 ELECTROCARDIOCORDER RECORDER Del Mar Avionics | DSH |
| Feb 22, 1988 | K874313 | MODEL 492 SSR (TM) RECORDER Del Mar Avionics | DSH |
| Jan 6, 1988 | K872658 | MODEL 980-CARDIOSCOPE AT-3 ELECTROCARDIOGRAPH Del Mar Avionics | DPS |
| Sep 4, 1987 | K863387 | MULTIPLE Del Mar Avionics | DXK |
| Dec 10, 1986 | K863652 | MODEL 456 ELECTROCARDIORECORDER RECORDER Del Mar Avionics | DPS |
| Apr 30, 1986 | K860471 | DEL AMR MODEL 250 CARDIODISPLAY HOLTER SCANNER Del Mar Avionics | DSI |
| Apr 30, 1986 | K860470 | DEL MAR MODEL 750 INNOVATOR HOLTER MANAGEMENT SYST Del Mar Avionics | DSI |
| Apr 11, 1986 | K854269 | MODEL 509A PHYSIOCORDER AMBULATORY RECORDER Del Mar Avionics | DSH |
| Mar 27, 1986 | K854268 | DEL MAR AVIONICS 5509A PHYSIOSCANNER EEG SCANNER Del Mar Avionics | GWQ |
| Jun 10, 1985 | K844896 | DEL MAR AVIONICS 8300 SECTOR IMAGER SYS Del Mar Avionics | DXK |
| Apr 4, 1985 | K850044 | TREADMILL E-17 Del Mar Avionics | IOL |
| Feb 8, 1985 | K850043 | CARDIOGUARD STRESS TEST MONITOR 4002 Del Mar Avionics | DRT |
| Dec 11, 1984 | K841654 | DEL MAR AVIONICS 509 NEUROCORDER AMBUL Del Mar Avionics | DSH |
| Dec 3, 1984 | K841653 | DEL MAR AVIONICS 5509 NEURO-SCANNER Del Mar Avionics | GWQ |
| Jul 2, 1984 | K840622 | CARDIO EXPRESS 100 HOLTER SCANNER Del Mar Avionics | DSI |
| Nov 28, 1983 | K833661 | ELECTROCARDIOCORDER RECORDER 453 Del Mar Avionics | DSH |
| Oct 22, 1982 | K822815 | MODEL 700 GASTROREFLUX MONITOR/AMALYZER Del Mar Avionics | FFT |
| Oct 8, 1982 | K822751 | DEL MAR AVIONICS MODEL 551 NEUROCORDER Del Mar Avionics | |
| Oct 6, 1982 | K822624 | O.T.E. BIOMEDICA B.A.S.I.S. MODEL 2381 Del Mar Avionics | IKN |
| Oct 4, 1982 | K822700 | DEL MAR MODEL 5500 EEG SCANNER Del Mar Avionics | GWQ |
| May 7, 1982 | K820653 | OTE BIOMEDICA BERG FOURIER ANALYZER Del Mar Avionics | OLT |
| Apr 26, 1982 | K820779 | OTE BIOMEDICAL #1296 - 16 CHAN. RECORD Del Mar Avionics | GWQ |
| Mar 23, 1982 | K820605 | OTE BIOMEDICA NEUROGRAPH 18 Del Mar Avionics | GWQ |
| Mar 23, 1982 | K820604 | OTE BIOMEDICA NEUROGRAPH 9 Del Mar Avionics | GWQ |
| Mar 23, 1982 | K820603 | OTE BIOMEDICA NEUROGRAPH 14 Del Mar Avionics | GWQ |
| Dec 29, 1981 | K813222 | MODEL 4200 ELLESTAD STRESS TEST ANALYZER Del Mar Avionics | DXG |
| Jun 12, 1981 | K811122 | DEL MAR AVIONICS MODELS 9400 & 9401 Del Mar Avionics | DSI |
| Sep 9, 1980 | K801831 | EVALUATOR #9500 DYNAMIC ELEC/SCANNER Del Mar Avionics | DSI |
| Aug 27, 1980 | K801832 | MODEL 9200 VIS-U-SCAN Del Mar Avionics | DSH |
| Aug 27, 1980 | K801830 | MODEL 9300 ELECTROCARDIOVALIDATOR Del Mar Avionics | DSF |
| Dec 27, 1979 | K792079 | MODEL 447 ELECTROCARDIOCORDER Del Mar Avionics | DSH |
| Dec 27, 1979 | K792078 | MODEL 449 ELECTROCARDIOCORDER Del Mar Avionics | DSH |
| Dec 27, 1979 | K792076 | MODEL 448 PACERCORDER Del Mar Avionics | DSH |
| Dec 27, 1979 | K792074 | MODEL 674 PACER ANALYZER Del Mar Avionics | DTC |
| Dec 4, 1979 | K792080 | MODEL 656 ARRHYTHMIA ANALYZER Del Mar Avionics | DXG |
| Dec 4, 1979 | K792077 | MODEL 1981 PRESSUROMETER DATA ANALYSIS Del Mar Avionics | DSK |
| Dec 4, 1979 | K792075 | MODEL 1978 PRESSUROMETER III AMBULATORY Del Mar Avionics | DXN |
| Dec 4, 1979 | K792071 | DCG DATA TERMINAL Del Mar Avionics |
Newest 50 of 54.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||