AFH, AFH FLEX, AFH/T, AFH/T FLEX, AF— 510(k) K941436

Substantially Equivalent

Icor AB

FDA 510(k) clearance K941436 for AFH, AFH FLEX, AFH/T, AFH/T FLEX, AF, Substantially Equivalent on 1994-06-08. Applicant: Icor AB. Device class: 1.

Clearance details

Applicant: Icor AB
Product code: Code BYD
Device class: Class 1
Regulation: 21 CFR 868.5375
Advisory panel: Anesthesiology
Date received: 1994-03-24
Decision date: 1994-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bromma, SE

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Recent devices under product code BYD

K955008 — HEAT & MOISTURE EXCHANGER1996-01-30
K954194 — DISPOSABLE HME/FILTER1995-10-20
K953580 — HEAT MOISTURE EXCHANGER1995-09-15
K953507 — TYPE 1 & 2 (HUMIDAIR I & II)1995-09-07
K953491 — HUMID-VENT 1 PORT/HUMID-VENT 1 PORT ANGLE1995-08-25

More clearances from Icor AB

K954402 — ET-TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)1996-05-22
K952325 — ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)1995-07-31
K952823 — FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE1995-07-13
K941987 — HEAT AND MOISTURE EXCHANGERS AND FILTERS1994-08-15
K940041 — COLIBRI1994-07-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.