Kontron Instruments, Inc.
Mchenry, IL, US
Kontron Instruments, Inc. appears in FDA device records in Mchenry, IL. FDA records list 58 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 58
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 58FDA records hold 58 510(k) clearances for Kontron Instruments, Inc. between 1981 and 1997. The busiest year on record is 1989, with 12. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 4 |
| 1982 | 3 |
| 1983 | 2 |
| 1984 | 2 |
| 1985 | 7 |
| 1986 | 5 |
| 1987 | 3 |
| 1988 | 11 |
| 1989 | 12 |
| 1990 | 3 |
| 1991 | 2 |
| 1993 | 3 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K971038 | KONTRON KOLORMON PLUS ECG WITH RESPIRATION MODULE | DPS | Substantially Equivalent | |
| K932268 | MODIFICATIONS TO INTRA-AORTIC BALLOONS | DSP | Substantially Equivalent | |
| K925248 | MODIFICATION OF INTRA-AORTIC BALLOON CATHETERS | DSP | Substantially Equivalent | |
| K923603 | INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION | DYB | Substantially Equivalent | |
| K905313 | KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II | DSP | Substantially Equivalent | |
| K903344 | 9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM) | DSP | Substantially Equivalent | |
| K896437 | KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM | DPT | Substantially Equivalent | |
| K892222 | 9.5F PERCU DOUBLE LUMEN INTRA-AORTIC BALLOON | DSP | Substantially Equivalent | |
| K882955 | SUPERMON NEONATAL NON-INVASIVE BLOOD PRESS. 7283 | DXN | Substantially Equivalent | |
| K896386 | MINIMON 7133B PATIENT MONITOR | DPS | Substantially Equivalent | |
| K896417 | KONTRON KOLORMON 7250 PATIENT MONITOR | DPS | Substantially Equivalent | |
| K895425 | MINIMON 7137B PATIENT MONITOR | DQA | Substantially Equivalent | |
| K892799 | 8 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON | DSP | Substantially Equivalent | |
| K892798 | 9 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON | DSP | Substantially Equivalent | |
| K892797 | 10 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOON | DSP | Substantially Equivalent | |
| K892878 | KONTRON INTRA-AORTIC BALLOON PUMP MODEL K9000 | DSP | Substantially Equivalent | |
| K882206 | SUPERMON ARRHYTHMIA MODULE 7270 | DSI | Substantially Equivalent | |
| K882508 | 9.5 FRENCH PERCUTANEOUS DOUBLE LUMEN BALLOON | DSP | Substantially Equivalent | |
| K882274 | 10.5 FRENCH PERCUTANEOUS DOUBLE LUMEN INTRA-AORTIC | DSP | Substantially Equivalent | |
| K890299 | KONTRON PULSE OXIMETER 7840 | DQA | Substantially Equivalent | |
| K883069 | MINIMON 7134B PATIENT MONITOR | DRT | Substantially Equivalent | |
| K873624 | KONTRON PULSE OXIMETER 7840 | DQA | Substantially Equivalent | |
| K882197 | MINIMON 7131B PATIENT MONITOR | DPS | Substantially Equivalent | |
| K882673 | SIGMA 1 WOBBLER BIOPSY KIT | FCH | Substantially Equivalent | |
| K882198 | MINIMON 7132B PATIENT MONITOR | DPS | Substantially Equivalent | |
| K873396 | KONTRON CAPNOGRAPH MONITOR, SUPERMON MODULE 7281 | CCK | Substantially Equivalent | |
| K875036 | INTRA-AORTIC BALLOON PUMP MODEL KAAT | DSP | Substantially Equivalent | |
| K874816 | KONTRON INTRA-AORTIC BALLOON PUMP MODEL K2000 | DSP | Substantially Equivalent | |
| K875371 | KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM | HGL | Substantially Equivalent | |
| K875334 | KONTRON SIGMA 1 DIGITAL ECHOCARDIOGRAPH SYSTEM | HGL | Substantially Equivalent | |
| K870816 | KONTRON STRESSDATA STRESS DATA MANAGEMENT SYSTEM | DSI | Substantially Equivalent | |
| K870815 | KONTRON E.E.G. MONITOR, SUPERMON MODULE 7265 | GWQ | Substantially Equivalent | |
| K861374 | SUPERMON NON-INVASIVE BLOOD PRESSURE MODULE 7282 | DXN | Substantially Equivalent | |
| K862686 | KONTRON SIGMA 1SC DIGITAL ECHOCARDIOGRAPHY SYSTEM | ITX | Substantially Equivalent | |
| K862261 | KONTRON SUPERMON CARDIAC OUTPUT MODULE 7263 | DXG | Substantially Equivalent | |
| K852249 | KONTRON VITALMON 5010 PATIENT MONITOR | BZQ | Substantially Equivalent | |
| K860638 | NOVEMPERC DOUBLE LUMEN INTRA-AORTIC BALLOON | DSP | Substantially Equivalent | |
| K860427 | KONTRON INTRA-AORTIC BALLOON PUMP MODEL KAAT | DSP | Substantially Equivalent | |
| K860951 | KONTRON CUTANEOUS PO2 MONITOR 820 | KLK | Substantially Equivalent | |
| K853062 | INTRA-AORTIC BALLOON PUMP MODEL K2000 | DSP | Substantially Equivalent | |
| K854307 | KONTRON DEFIBRILLATOR 7501 | LDD | Substantially Equivalent | |
| K852543 | KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM | DXK | Substantially Equivalent | |
| K842422 | KONTRON FAX FETAL MONITOR | HGM | Substantially Equivalent | |
| K844731 | KONTRON SUPERMON 7210 PATIENT MONITOR | DRT | Substantially Equivalent | |
| K844215 | KONTRON MINIMON 7134 PATIENT MONITOR | DRT | Substantially Equivalent | |
| K844733 | KONTRON MINIMON 7131 PATIENT MONITOR | DRT | Substantially Equivalent | |
| K844732 | KONTRON MINIMON 7132 PATIENT MONITOR | DRT | Substantially Equivalent | |
| K843355 | TRANSDUCER FOR KONTROL 5MHZ SIGMA 20 | MHZ | Substantially Equivalent | |
| K833680 | SIGMA 20 ELECTRONIC SECTOR SCANNER | IYO | Substantially Equivalent | |
| K831733 | TEMPERATURE MODULE 242-100 | FLL | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function
- DQKComputer, Diagnostic, Programmable
- FLLContinuous Measurement Thermometer
- LDDDc-Defibrillator, Low-Energy, (Including Paddles)
- DSIDetector And Alarm, Arrhythmia
- DXKEchocardiograph
- DPSElectrocardiograph
- HGPElectrode, Circular (Spiral), Scalp And Applicator
- GWQFull-Montage Standard Electroencephalograph
- DYBIntroducer, Catheter
- BZQMonitor, Breathing Frequency
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
- DQAOximeter
- DPTProbe, Blood-Flow, Extravascular
- MHZStimulator, Vestibular Acceleration, Therapeutic
- DSPSystem, Balloon, Intra-Aortic And Control
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- HGMSystem, Monitoring, Perinatal
- JABSystem, X-Ray, Fluoroscopic, Non-Image-Intensified
- ITXTransducer, Ultrasonic, Diagnostic
- HGLTransducer, Ultrasonic, Obstetric
- FCHTray, Biopsy, Without Biopsy Instruments
- CBKVentilator, Continuous, Facility Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain