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FDA 510(k)

ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)

K-Number: K952325 · 1995-07-31

ApplicantIcor AB
Decision Date1995-07-31
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR) is the device name listed in this FDA 510(k) record. The listed applicant is Icor AB. It received FDA 510(k) clearance on 1995-07-31 under 510(k) number K952325. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)?

ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR) is a medical device that received FDA 510(k) clearance on 1995-07-31. The listed applicant is Icor AB. The 510(k) number is K952325.

When did ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR) receive FDA 510(k) clearance?

ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR) received FDA 510(k) clearance on 1995-07-31, under 510(k) number K952325.

Who is the listed applicant for ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)?

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 ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR)?

The FDA product code for ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR) is CCK.

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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)K952823FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBEK941987HEAT AND MOISTURE EXCHANGERS AND FILTERSK940041COLIBRIK941436AFH, AFH FLEX, AFH/T, AFH/T FLEX, AF

View all 16 devices →

Related Devices (Code: CCK)

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.

K251641GF-310R Multigas Unit (GF-310R)Nihon Kohden CorporationK261633VisuBreathAffirm Medical Technologies II, LLCK253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLCK250148Medical Gas Analyzer (AG200)Prior Care Science Technology, Ltd.K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)Nihon Kohden CorporationK2512160184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling lineBarbaras Development, 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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