FDA Product Code
FDA Product Code DXG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1435
510(k) Clearances — 177 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K844682 | ELECATH CARDIAC OUTPUT COMPUTER | Electro-Catheter Corp. | 1985-03-06 | Traditional | PDF ↗ |
| K844277 | OMIKRON PACEMAKER 837 UNIPOLAR & 838 BIPOLAR | Omikron Scientific, Ltd. | 1985-02-15 | Traditional | PDF ↗ |
| K844665 | COMPUTER | Burdick Corp. | 1985-02-13 | Traditional | PDF ↗ |
| K843555 | CARDIAC COMPUTER SP1445 | Gould, Inc. | 1985-02-01 | Traditional | PDF ↗ |
| K842105 | RIGHT VENTRICULAR EJECTION FRACTION- | American Edwards Laboratories | 1985-01-15 | Traditional | PDF ↗ |
| K841401 | SAT-1 OXIMETER/CARDIAC OUTPUT COMPUTER | American Edwards Laboratories | 1985-01-14 | Traditional | PDF ↗ |
| K842706 | SCATAID | Sc Applied Technology, Inc. | 1984-11-27 | Traditional | PDF ↗ |
| K840439 | RECOMED CARDIAC OUTPUT METER 236067- | Litton Medical Electronics | 1984-11-20 | Traditional | PDF ↗ |
| K844022 | ELECATH VENTRICULAR PACING THERMAL DILUTION CATH | Electro-Catheter Corp. | 1984-11-20 | Traditional | PDF ↗ |
| K841256 | MODELS 78551A 78552A | Hewlett-Packard Co. | 1984-10-02 | Traditional | PDF ↗ |
| K842831 | BAIM CORONARY SINUS FLOW CALCULATOR | Electro-Catheter Corp. | 1984-08-27 | Traditional | PDF ↗ |
| K834408 | TX-2 THERMAL DILUTION CARDIAC OUTPUT | Waters Instruments, Inc. | 1984-08-23 | Traditional | PDF ↗ |
| K840009 | NOVA 12 CARDIAC OUTPUT COMPUTER | Nova Medical Specialties | 1984-08-22 | Traditional | PDF ↗ |
| K841261 | COMPUTER, CENTRAL PROCESSING UNIT | Nem Computer Corp. | 1984-08-10 | Traditional | PDF ↗ |
| K833756 | SYSTEM 5000 | Medical Graphics Corp. | 1984-04-24 | Traditional | PDF ↗ |
| K833913 | HEMODYNAMIC PLUG-IN MODULE 78551A | Hewlett-Packard Co. | 1984-03-22 | Traditional | PDF ↗ |
| K833914 | CARDIAC OUTPUT SIGNAL ACQUISTION | Hewlett-Packard Co. | 1984-03-22 | Traditional | PDF ↗ |
| K832644 | ALPHA CARDIAC OUTPUT CARDULE #1899 | Spacelabs, Inc. | 1984-01-27 | Traditional | PDF ↗ |
| K833395 | SENTINEL SYSTEMS | Quantitative Medicine, Inc. | 1984-01-10 | Traditional | PDF ↗ |
| K831967 | CRITIKON CARDIAC OUTPUT COMPUTER | Critikon Company, LLC | 1983-10-28 | Traditional | PDF ↗ |
| K831057 | VIDEO-DILUTION TECH. MARK I INSTRUMENT | Angio Tec Corp. | 1983-10-19 | Traditional | PDF ↗ |
| K831407 | CARDIAC OUTPUT COMPUTER | Ziehm International, Inc. | 1983-10-14 | Traditional | PDF ↗ |
| K830892 | THERMODILUTION CARDIAC OUTPUT COMPUTER- | American Edwards Laboratories | 1983-06-15 | Traditional | PDF ↗ |
| K830628 | REAL-TIME SPECTRUM ANALYZER | Diagnostic Electronics Corp. | 1983-06-02 | Traditional | PDF ↗ |
| K830003 | MICRO FITNESS COMPUTER | Microfit, Inc. | 1983-03-10 | Traditional | PDF ↗ |
| K822903 | AUTOECHO | Oxford Medilog, Inc. | 1982-11-01 | Traditional | PDF ↗ |
| K822972 | IL 801 THERMALDILUTION CARDIAC OUTPUT | Instrumentation Laboratory CO | 1982-11-01 | Traditional | PDF ↗ |
| K822877 | MODEL 78554A DATA MGMT. PLUG-IN MODULE | Hewlett-Packard Co. | 1982-10-18 | Traditional | PDF ↗ |
| K822093 | STAT-SCAN | Survival Technology, Inc. | 1982-09-21 | Traditional | PDF ↗ |
| K820194 | CARDIAC CATHERIZATION LAB MICROPROCESS | Compu-Cath Corp. | 1982-05-25 | Traditional | PDF ↗ |
| K820820 | CARDIO REVUE CENTER | Diasonics, Inc. | 1982-04-29 | Traditional | PDF ↗ |
| K820898 | VASCULAB SPECTRUM ANALYZER #SP25 | Medasonics, Inc. | 1982-04-21 | Traditional | PDF ↗ |
| K813223 | DISPOSABLE PLASTIC SYRINGE W/NEEDLE | Sam Joo Industrial Co., Ltd. | 1982-04-15 | Traditional | PDF ↗ |
| K812971 | CARDIOINTEGRAM | Ocg Technology, Inc. | 1981-12-29 | Traditional | PDF ↗ |
| K813222 | MODEL 4200 ELLESTAD STRESS TEST ANALYZER | Del Mar Avionics | 1981-12-29 | Traditional | PDF ↗ |
| K813020 | BOMED-NCCOM | Bomed Medical Mfr., Ltd. | 1981-12-14 | Traditional | PDF ↗ |
| K812932 | ANERIOD GAUZE | Abco Dealers, Inc. | 1981-12-02 | Traditional | PDF ↗ |
| K812638 | DIAGNOSTIC MEDICAL COMPUTER | Diagnostic Resources, Inc. | 1981-11-16 | Traditional | PDF ↗ |
| K812757 | SORENSON THERMODILUTION CARDIAC COMPUT | Sorensen Research | 1981-11-02 | Traditional | PDF ↗ |
| K812515 | CARDIAC REVIEW STATION | Diasonics, Inc. | 1981-10-02 | Traditional | PDF ↗ |
| K811560 | AUTOMATED PHYSIOLOGIC PROFILE MONITOR | Life Sciences Manufacturing, Inc. | 1981-06-18 | Traditional | PDF ↗ |
| K811414 | BAIM CORONARY SINUS FLOW ANALYZER | Electro-Catheter Corp. | 1981-06-12 | Traditional | PDF ↗ |
| K811062 | CAMPBRIDGE COMPUTRACE | Cambridge Instruments, Inc. | 1981-05-29 | Traditional | PDF ↗ |
| K810851 | SPECTRUM ANALYZER 8000 | Radionics Medical, Inc. | 1981-04-23 | Traditional | PDF ↗ |
| K810163 | AM 420 MICROPROCESSOR | Honeywell, Inc. | 1981-03-05 | Traditional | PDF ↗ |
| K810177 | PATIENT MONITOR MODEL CM130, 140 | Honeywell, Inc. | 1981-02-25 | Traditional | PDF ↗ |
| K810170 | TREND GRAPH FUNCTION BLOCK | Honeywell, Inc. | 1981-02-25 | Traditional | PDF ↗ |
| K802316 | PDS THERMAL DILUTION CARDIAC MODULE(OUT) | General Electric Co. | 1980-11-26 | Traditional | PDF ↗ |
| K802800 | NARCO AIR-SHEILDS SYS. 100 MONITOR SYS | Narco Air-Shields | 1980-11-24 | Traditional | PDF ↗ |
| K802476 | CARDIACINDEX COMPUTER MODEL SP 1435 | Gould, Inc. | 1980-11-19 | Traditional | PDF ↗ |
| K802305 | MLC-4200 CARDIAC OUTPUT COMPUTER | Nihon Kohden America, Inc. | 1980-10-10 | Traditional | PDF ↗ |
| K802198 | BIOMETRIC SYSTOLIC TIME INTERVAL SYSTEM | Biometric Analysis Group, Inc. | 1980-09-26 | Traditional | PDF ↗ |
| K792678 | CARDIAC OUTPUT COMPUTER, M-MLC-4100 | Nihon Kohden America, Inc. | 1980-01-09 | Traditional | PDF ↗ |
| K792080 | MODEL 656 ARRHYTHMIA ANALYZER | Del Mar Avionics | 1979-12-04 | Traditional | PDF ↗ |
| K791756 | VDC | Life Sciences Manufacturing, Inc. | 1979-11-27 | Traditional | PDF ↗ |
| K791753 | IPAG MICRONOVA INTERFACE #781111 | Robinton Corp. | 1979-10-02 | Traditional | PDF ↗ |
| K790288 | STORAGE, DIGITAL DSC-1, CONTROL UNIT | Oxford Medilog, Inc. | 1979-02-27 | Traditional | PDF ↗ |
| K790047 | CARDIAC OUTPUT COMPUTER, MDEL 9520A | Edwards Laboratories | 1979-02-26 | Traditional | PDF ↗ |
| K781805 | CARDIAC COMPUTERS, CO-10 & CO-10R | Waters Assoc., Inc. | 1979-01-29 | Traditional | PDF ↗ |
| K781855 | LVV OPTION | Honeywell, Inc. | 1979-01-05 | Traditional | PDF ↗ |
| K781535 | AC ADAPTER:MODELS 9525,9526,9527 | Edwards Laboratories | 1978-09-15 | Traditional | PDF ↗ |
| K772152 | CENTRAL MONITORING SYSTEM | Burdick Corp. | 1977-11-28 | Traditional | PDF ↗ |
| K771924 | HEARTBEATER | Dunn Instruments, Inc. | 1977-11-28 | Traditional | PDF ↗ |
| K772158 | LIGHT-PEN SYSTEM FOR QUANTI. ANALY. | Varian Assoc., Inc. | 1977-11-22 | Traditional | PDF ↗ |
| K771991 | CARDIAC OUTPUT THERMODILUTION MODULE | Abbott Laboratories | 1977-11-03 | Traditional | PDF ↗ |
| K771666 | SPHYGMOMANOMETER #1235 | Sears, Roebuck & Co. | 1977-09-30 | Traditional | PDF ↗ |
| K771718 | CARDIOTHERM-500X | Columbus Instruments Intl. Corp. | 1977-09-28 | Traditional | PDF ↗ |
| K770675 | COMPUTER, CARDIAC OUTPUT, MODEL KM275 | Lexington Instruments | 1977-04-26 | Traditional | PDF ↗ |
| K770179 | CARDIAC CATHETERIZATION LAB MONITOR SYS | General Electric Co. | 1977-04-05 | Traditional | PDF ↗ |
| K770330 | MONITOR, PULSE WAVE VELOCITY P607 | Cyborg Corp. | 1977-02-24 | Traditional | PDF ↗ |
| K761166 | TC-1 CARDIAC OUTPUT COMPUTER | Waters Assoc., Inc. | 1976-12-09 | Traditional | PDF ↗ |
| K760844 | CARDIAC OUTPUT COMPUTER (MODEL COC-100) | B-D Electrodyne | 1976-11-12 | Traditional | PDF ↗ |
| K760756 | BATTERY OPERATED FLOW RATE COMPUTER | 3M Health Care, Sarns | 1976-10-15 | Traditional | PDF ↗ |
| K760600 | CARDIAC OUTPUT COMPUTER | Cardiopulmonary Instrumentation | 1976-10-15 | Traditional | PDF ↗ |
| K760774 | TIME-SHARING MULTIPLEXER (MODEL 78308A) | Hewlett-Packard Co. | 1976-10-13 | Traditional | PDF ↗ |
| K760532 | COMPUTER, CARDIAC OUTPUT (#SP1425) | Gould, Inc. | 1976-09-09 | Traditional | PDF ↗ |
| K760192 | COMPUTER, THERMODILUTION CARDIAC (9520) | Edwards Laboratories | 1976-07-19 | Traditional | PDF ↗ |
Product code DXG · Class II · Cardiovascular. Data: openFDA.