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510(k) K940041

COLIBRI by Icor AB — Product Code BTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1994
Date Received
January 4, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Tracheal (W/Wo Connector)
Device Class
Class II
Regulation Number
868.5730
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)
  • K952325 — ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR) (July 31, 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)
  • 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)

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