Medical Device Manufacturer · SE , Bromma

Icor AB - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 1986

16

Total

16

Cleared

0

Denied

FDA 510(k) Regulatory Record - Icor AB Anesthesiology ✕

15 devices

1-15 of 15

Cleared May 22, 1996

ET-TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)

Anesthesiology · 245d

Cleared Sep 07, 1995

TYPE 1 & 2 (HUMIDAIR I & II)

Anesthesiology · 43d

Cleared Jul 31, 1995

ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)

Anesthesiology · 74d

Cleared Jul 13, 1995

FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT...

Anesthesiology · 23d

Cleared Aug 15, 1994

HEAT AND MOISTURE EXCHANGERS AND FILTERS

Anesthesiology · 112d

Cleared Jul 27, 1994

Anesthesiology · 204d

Cleared Jun 08, 1994

AFH, AFH FLEX, AFH/T, AFH/T FLEX, AF

Anesthesiology · 76d

Cleared May 26, 1993

FHB, FHB-T, FHBFLEX, FHBFLEX-T

Anesthesiology · 201d

Cleared Dec 04, 1990

ICOR HCH 4, ICOR HCH 7

Anesthesiology · 75d

Cleared Jan 25, 1990

HCH 9165, 9165 S, 9166, HFH, HFH-T HEAT MOISTURE

Anesthesiology · 14d

Cleared Jan 04, 1990

ICOR CMU Q PLUS

Anesthesiology · 85d

Cleared Nov 04, 1988

ICOR AGENT MONITOR

Anesthesiology · 78d

Cleared May 17, 1988

Anesthesiology · 50d

Cleared Sep 04, 1987

ICOR NEONATAL HCH

Anesthesiology · 77d

Cleared Mar 27, 1986

ICOR CALARIC MEASUREMENT UNIT (CMU)

Anesthesiology · 107d