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FDA 510(k)

COLIBRI

K-Number: K940041 · 1994-07-27

ApplicantIcor AB
Decision Date1994-07-27
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

COLIBRI is the device name listed in this FDA 510(k) record. The listed applicant is Icor AB. It received FDA 510(k) clearance on 1994-07-27 under 510(k) number K940041. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLIBRI?

COLIBRI is a medical device that received FDA 510(k) clearance on 1994-07-27. The listed applicant is Icor AB. The 510(k) number is K940041.

When did COLIBRI receive FDA 510(k) clearance?

COLIBRI received FDA 510(k) clearance on 1994-07-27, under 510(k) number K940041.

Who is the listed applicant for COLIBRI?

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 COLIBRI?

The FDA product code for COLIBRI is BTR.

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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 FILTERSK941436AFH, AFH FLEX, AFH/T, AFH/T FLEX, AF

View all 16 devices →

Related Devices (Code: BTR)

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.

K251794Tenax® Laser Resistant Endotracheal TubeBryan Medical, Inc.K253437Spiro-VISTASpiro RoboticsK250173Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR)Covidien, LLCK243785Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless ReinforcedCovidien, LLCK243579AeroJet Ventilation CatheterPipeline Medical Products, LLCK251499Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)William Cook Europe Aps

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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