Company ยท US
Kontron Instruments, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 1997. Name variants (Inc, Corp, punctuation) are merged.
58510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DSP | System, Balloon, Intra-Aortic And Control | 17 |
| DPS | Electrocardiograph | 5 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 5 |
| DQA | Oximeter | 3 |
| DSI | Detector And Alarm, Arrhythmia | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 |
| HGL | Transducer, Ultrasonic, Obstetric | 2 |
| HGM | System, Monitoring, Perinatal | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 |
| BZQ | Monitor, Breathing Frequency | 1 |
| CBK | Ventilator, Continuous, Facility Use | 1 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 |
| DPT | Probe, Blood-Flow, Extravascular | 1 |
| DQK | Computer, Diagnostic, Programmable | 1 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 1 |
| DXK | Echocardiograph | 1 |
| DYB | Introducer, Catheter | 1 |
| FCH | Tray, Biopsy, Without Biopsy Instruments | 1 |
| FLL | Continuous Measurement Thermometer | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 24, 1997 | K971038 | KONTRON KOLORMON PLUS ECG WITH RESPIRATION MODULE Kontron Instruments , Ltd., GB | DPS |
| Dec 15, 1993 | K932268 | MODIFICATIONS TO INTRA-AORTIC BALLOONS Kontron Instruments, Inc. | DSP |
| Sep 27, 1993 | K925248 | MODIFICATION OF INTRA-AORTIC BALLOON CATHETERS Kontron Instruments, Inc. | DSP |
| Mar 8, 1993 | K923603 | INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION Kontron Instruments, Inc. | DYB |
| Jun 19, 1991 | K905313 | KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II Kontron Instruments, Inc. | DSP |
| Jan 15, 1991 | K903344 | 9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM) Kontron Instruments, Inc. | DSP |
| Dec 3, 1990 | K896437 | KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM Kontron Instruments, Inc. | DPT |
| Sep 14, 1990 | K892222 | 9.5F PERCU DOUBLE LUMEN INTRA-AORTIC BALLOON Kontron Instruments, Inc. | DSP |
| Jan 26, 1990 | K882955 | SUPERMON NEONATAL NON-INVASIVE BLOOD PRESS. 7283 Kontron Instruments, Inc. | DXN |
| Dec 13, 1989 | K896386 | MINIMON 7133B PATIENT MONITOR Kontron Instruments, Inc. | DPS |
| Dec 12, 1989 | K896417 | KONTRON KOLORMON 7250 PATIENT MONITOR Kontron Instruments, Inc. | DPS |
| Sep 26, 1989 | K895425 | MINIMON 7137B PATIENT MONITOR Kontron Instruments, Inc. | DQA |
| Sep 20, 1989 | K892799 | 8 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON Kontron Instruments, Inc. | DSP |
| Sep 20, 1989 | K892798 | 9 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON Kontron Instruments, Inc. | DSP |
| Sep 20, 1989 | K892797 | 10 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON Kontron Instruments, Inc. | DSP |
| Sep 13, 1989 | K892878 | KONTRON INTRA-AORTIC BALLOON PUMP MODEL K9000 Kontron Instruments, Inc. | DSP |
| Apr 5, 1989 | K882206 | SUPERMON ARRHYTHMIA MODULE 7270 Kontron Instruments, Inc. | DSI |
| Mar 20, 1989 | K882508 | 9.5 FRENCH PERCUTANEOUS DOUBLE LUMEN BALLOON Kontron Instruments, Inc. | DSP |
| Mar 20, 1989 | K882274 | 10.5 FRENCH PERCUTANEOUS DOUBLE LUMEN INTRA-AORTIC Kontron Instruments, Inc. | DSP |
| Mar 2, 1989 | K890299 | KONTRON PULSE OXIMETER 7840 Kontron Instruments, Inc. | DQA |
| Jan 17, 1989 | K883069 | MINIMON 7134B PATIENT MONITOR Kontron Instruments, Inc. | DRT |
| Oct 19, 1988 | K873624 | KONTRON PULSE OXIMETER 7840 Kontron Instruments, Inc. | DQA |
| Aug 12, 1988 | K882197 | MINIMON 7131B PATIENT MONITOR Kontron Instruments, Inc. | DPS |
| Jul 28, 1988 | K882673 | SIGMA 1 WOBBLER BIOPSY KIT Kontron Instruments, Inc. | FCH |
| Jul 28, 1988 | K882198 | MINIMON 7132B PATIENT MONITOR Kontron Instruments, Inc. | DPS |
| Jun 21, 1988 | K873396 | KONTRON CAPNOGRAPH MONITOR, SUPERMON MODULE 7281 Kontron Instruments, Inc. | CCK |
| May 18, 1988 | K875036 | INTRA-AORTIC BALLOON PUMP MODEL KAAT Kontron Instruments, Inc. | DSP |
| Apr 1, 1988 | K874816 | KONTRON INTRA-AORTIC BALLOON PUMP MODEL K2000 Kontron Instruments, Inc. | DSP |
| Mar 24, 1988 | K875371 | KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM Kontron Instruments, Inc. | HGL |
| Mar 24, 1988 | K875334 | KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM Kontron Instruments, Inc. | HGL |
| Mar 1, 1988 | K870816 | KONTRON STRESSDATA STRESS DATA MANAGEMENT SYSTEM Kontron Instruments, Inc. | DSI |
| Feb 1, 1988 | K870815 | KONTRON E.E.G. MONITOR, SUPERMON MODULE 7265 Kontron Instruments, Inc. | GWQ |
| Jul 21, 1987 | K861374 | SUPERMON NON-INVASIVE BLOOD PRESSURE MODULE 7282 Kontron Instruments, Inc. | DXN |
| Feb 27, 1987 | K862686 | KONTRON SIGMA 1SC DIGITAL ECHOCARDIOGRAPHY SYSTEM Kontron Instruments, Inc. | ITX |
| Feb 19, 1987 | K862261 | KONTRON SUPERMON CARDIAC OUTPUT MODULE 7263 Kontron Instruments, Inc. | DXG |
| Oct 16, 1986 | K852249 | KONTRON VITALMON 5010 PATIENT MONITOR Kontron Instruments, Inc. | BZQ |
| Oct 1, 1986 | K860638 | NOVEMPERC DOUBLE LUMEN INTRA-AORTIC BALLOON Kontron Instruments, Inc. | DSP |
| May 7, 1986 | K860427 | KONTRON INTRA-AORTIC BALLOON PUMP MODEL KAAT Kontron Instruments, Inc. | DSP |
| Apr 9, 1986 | K860951 | KONTRON CUTANEOUS PO2 MONITOR 820 Kontron Instruments, Inc. | KLK |
| Jan 22, 1986 | K853062 | INTRA-AORTIC BALLOON PUMP MODEL K2000 Kontron Instruments, Inc. | DSP |
| Dec 4, 1985 | K854307 | KONTRON DEFIBRILLATOR 7501 Kontron Instruments, Inc. | LDD |
| Sep 20, 1985 | K852543 | KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM Kontron Instruments, Inc. | DXK |
| Sep 20, 1985 | K842422 | KONTRON FAX FETAL MONITOR Kontron Instruments, Inc. | HGM |
| May 16, 1985 | K844731 | KONTRON SUPERMON 7210 PATIENT MONITOR Kontron Instruments, Inc. | DRT |
| Apr 4, 1985 | K844215 | KONTRON MINIMON 7134 PATIENT MONITOR Kontron Instruments, Inc. | DRT |
| Mar 27, 1985 | K844733 | KONTRON MINIMON 7131 PATIENT MONITOR Kontron Instruments, Inc. | DRT |
| Mar 27, 1985 | K844732 | KONTRON MINIMON 7132 PATIENT MONITOR Kontron Instruments, Inc. | DRT |
| Dec 3, 1984 | K843355 | TRANSDUCER FOR KONTROL 5MHZ SIGMA 20 Kontron Instruments, Inc. | MHZ |
| Feb 17, 1984 | K833680 | SIGMA 20 ELECTRONIC SECTOR SCANNER Kontron Instruments, Inc. | IYO |
| Aug 24, 1983 | K831733 | TEMPERATURE MODULE 242-100 Kontron Instruments, Inc. | FLL |
Newest 50 of 58.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||