Home / 510(k) Clearances / K952325

510(k) K952325

ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR) by Icor AB — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 1995
Date Received
May 18, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1400
Review Panel
AN
Submission Type

Other clearances by Icor AB

  • K954402 — ET-TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR) (May 22, 1996)
  • K953507 — TYPE 1 & 2 (HUMIDAIR I & II) (September 7, 1995)
  • K952823 — FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXR (July 13, 1995)
  • K941987 — HEAT AND MOISTURE EXCHANGERS AND FILTERS (August 15, 1994)
  • K940041 — COLIBRI (July 27, 1994)
  • K941436 — AFH, AFH FLEX, AFH/T, AFH/T FLEX, AF (June 8, 1994)
  • K925622 — FHB, FHB-T, FHBFLEX, FHBFLEX-T (May 26, 1993)
  • K914416 — BREATH-EASY, MODIFICATION (June 23, 1992)
  • K904338 — ICOR HCH 4, ICOR HCH 7 (December 4, 1990)
  • K900150 — HCH 9165, 9165 S, 9166, HFH, HFH-T HEAT MOISTURE (January 25, 1990)

Other clearances for product code CCK

  • K250148 — Medical Gas Analyzer (AG200) (August 28, 2025)
  • K243956 — TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) (June 10, 2025)
  • K251216 — 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO (June 4, 2025)
  • K240937 — AIM (N/A) (December 16, 2024)
  • K230915 — AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask (November 12, 2024)
  • K212425 — MicroTrend System (November 7, 2024)
  • K222511 — Oxy2Pro (November 21, 2023)
  • K213767 — Endure ETCO2/02 Nasal Cannula (September 12, 2023)
  • K221118 — CO2 Mainstream Sensor (April 5, 2023)
  • K210112 — XChange Device, XChange System (January 30, 2023)