Icor AB

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
16
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K954402ET-TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)May 22, 1996
K953507TYPE 1 & 2 (HUMIDAIR I & II)September 7, 1995
K952325ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)July 31, 1995
K952823FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBEJuly 13, 1995
K941987HEAT AND MOISTURE EXCHANGERS AND FILTERSAugust 15, 1994
K940041COLIBRIJuly 27, 1994
K941436AFH, AFH FLEX, AFH/T, AFH/T FLEX, AFJune 8, 1994
K925622FHB, FHB-T, FHBFLEX, FHBFLEX-TMay 26, 1993
K914416BREATH-EASY, MODIFICATIONJune 23, 1992
K904338ICOR HCH 4, ICOR HCH 7December 4, 1990
K900150HCH 9165, 9165 S, 9166, HFH, HFH-T HEAT MOISTUREJanuary 25, 1990
K895935ICOR CMU Q PLUSJanuary 4, 1990
K883532ICOR AGENT MONITORNovember 4, 1988
K881308BREATH-EASYMay 17, 1988
K872371ICOR NEONATAL HCHSeptember 4, 1987
K854927ICOR CALARIC MEASUREMENT UNIT (CMU)March 27, 1986