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510(k) K941436

AFH, AFH FLEX, AFH/T, AFH/T FLEX, AF by Icor AB — Product Code BYD

K941436 is an FDA 510(k) premarket notification submitted by Icor AB for the device "AFH, AFH FLEX, AFH/T, AFH/T FLEX, AF". The FDA issued a decision of Substantially Equivalent on June 8, 1994. The device falls under product code BYD (Condenser, Heat And Moisture (Artificial Nose)), a Class I device regulated under 21 CFR 868.5375. Icor AB has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1994
Date Received
March 24, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condenser, Heat And Moisture (Artificial Nose)
Device Class
Class I
Regulation Number
868.5375
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)
  • K940041 — COLIBRI (July 27, 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 BYD

  • K955008 — HEAT & MOISTURE EXCHANGER (January 30, 1996)
  • K954194 — DISPOSABLE HME/FILTER (October 20, 1995)
  • K953580 — HEAT MOISTURE EXCHANGER (September 15, 1995)
  • K953507 — TYPE 1 & 2 (HUMIDAIR I & II) (September 7, 1995)
  • K953544 — HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHT (August 25, 1995)
  • K953540 — EEE (August 25, 1995)
  • K953620 — WARM N WET HMEF W/LUER ADAPTER (August 25, 1995)
  • K953491 — HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE (August 25, 1995)
  • K953619 — WARM N WET HME W/LUER ADAPTER (August 25, 1995)
  • K952845 — HUMID-VENT TRACH-VENT (July 25, 1995)

FDA data resources