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Kontron Instruments, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
58
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K971038KONTRON KOLORMON PLUS ECG WITH RESPIRATION MODULESeptember 24, 1997
K932268MODIFICATIONS TO INTRA-AORTIC BALLOONSDecember 15, 1993
K925248MODIFICATION OF INTRA-AORTIC BALLOON CATHETERSSeptember 27, 1993
K923603INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATIONMarch 8, 1993
K905313KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT IIJune 19, 1991
K9033449.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM)January 15, 1991
K896437KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEMDecember 3, 1990
K8922229.5F PERCU DOUBLE LUMEN INTRA-AORTIC BALLOONSeptember 14, 1990
K882955SUPERMON NEONATAL NON-INVASIVE BLOOD PRESS. 7283January 26, 1990
K896386MINIMON 7133B PATIENT MONITORDecember 13, 1989
K896417KONTRON KOLORMON 7250 PATIENT MONITORDecember 12, 1989
K895425MINIMON 7137B PATIENT MONITORSeptember 26, 1989
K8927989 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOONSeptember 20, 1989
K8927998 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOONSeptember 20, 1989
K89279710 FR PERCUTAN DOUBLE LUMEN INTRA-AORTIC BALLOONSeptember 20, 1989
K892878KONTRON INTRA-AORTIC BALLOON PUMP MODEL K9000September 13, 1989
K882206SUPERMON ARRHYTHMIA MODULE 7270April 5, 1989
K88227410.5 FRENCH PERCUTANEOUS DOUBLE LUMEN INTRA-AORTICMarch 20, 1989
K8825089.5 FRENCH PERCUTANEOUS DOUBLE LUMEN BALLOONMarch 20, 1989
K890299KONTRON PULSE OXIMETER 7840March 2, 1989