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FDA 510(k)

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

K-Number: K952823 · 1995-07-13

ApplicantIcor AB
Decision Date1995-07-13
Product CodeBYD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE is the device name listed in this FDA 510(k) record. The listed applicant is Icor AB. It received FDA 510(k) clearance on 1995-07-13 under 510(k) number K952823. The device is classified under product code BYD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE?

FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE is a medical device that received FDA 510(k) clearance on 1995-07-13. The listed applicant is Icor AB. The 510(k) number is K952823.

When did FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE receive FDA 510(k) clearance?

FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE received FDA 510(k) clearance on 1995-07-13, under 510(k) number K952823.

Who is the listed applicant for FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE?

The FDA 510(k) record lists Icor AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE?

The FDA product code for FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE is BYD.

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Other records listing Icor AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K954402ET-TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)K953507TYPE 1 & 2 (HUMIDAIR I & II)K952325ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)K941987HEAT AND MOISTURE EXCHANGERS AND FILTERSK940041COLIBRIK941436AFH, AFH FLEX, AFH/T, AFH/T FLEX, AF

View all 16 devices →

Related Devices (Code: BYD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K955008HEAT & MOISTURE EXCHANGERIntertech Resources, Inc.K954194DISPOSABLE HME/FILTEREngstrom MedicalK953580HEAT MOISTURE EXCHANGERIntertech Resources, Inc.K953507TYPE 1 & 2 (HUMIDAIR I & II)Icor ABK953544HUMID-VENT 2 LIGHT/HUMID-VENT 2 PORT LIGHTGibeck, Inc.K953620WARM N WET HMEF W/LUER ADAPTERHospitak, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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