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FDA 510(k)

FHB, FHB-T, FHBFLEX, FHBFLEX-T

K-Number: K925622 · 1993-05-26

ApplicantIcor AB
Decision Date1993-05-26
Product CodeBYD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FHB, FHB-T, FHBFLEX, FHBFLEX-T is the device name listed in this FDA 510(k) record. The listed applicant is Icor AB. It received FDA 510(k) clearance on 1993-05-26 under 510(k) number K925622. 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, FHBFLEX, FHBFLEX-T?

FHB, FHB-T, FHBFLEX, FHBFLEX-T is a medical device that received FDA 510(k) clearance on 1993-05-26. The listed applicant is Icor AB. The 510(k) number is K925622.

When did FHB, FHB-T, FHBFLEX, FHBFLEX-T receive FDA 510(k) clearance?

FHB, FHB-T, FHBFLEX, FHBFLEX-T received FDA 510(k) clearance on 1993-05-26, under 510(k) number K925622.

Who is the listed applicant for FHB, FHB-T, FHBFLEX, FHBFLEX-T?

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, FHBFLEX, FHBFLEX-T?

The FDA product code for FHB, FHB-T, FHBFLEX, FHBFLEX-T 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)K952823FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBEK941987HEAT AND MOISTURE EXCHANGERS AND FILTERSK940041COLIBRI

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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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