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FDA 510(k)

ICOR HCH 4, ICOR HCH 7

K-Number: K904338 · 1990-12-04

ApplicantIcor AB
Decision Date1990-12-04
Product CodeBYD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ICOR HCH 4, ICOR HCH 7 is the device name listed in this FDA 510(k) record. The listed applicant is Icor AB. It received FDA 510(k) clearance on 1990-12-04 under 510(k) number K904338. 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 ICOR HCH 4, ICOR HCH 7?

ICOR HCH 4, ICOR HCH 7 is a medical device that received FDA 510(k) clearance on 1990-12-04. The listed applicant is Icor AB. The 510(k) number is K904338.

When did ICOR HCH 4, ICOR HCH 7 receive FDA 510(k) clearance?

ICOR HCH 4, ICOR HCH 7 received FDA 510(k) clearance on 1990-12-04, under 510(k) number K904338.

Who is the listed applicant for ICOR HCH 4, ICOR HCH 7?

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 ICOR HCH 4, ICOR HCH 7?

The FDA product code for ICOR HCH 4, ICOR HCH 7 is BYD.

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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