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FDA 510(k)

INTUBATION KIT

K-Number: K832629 · 1983-09-20

ApplicantCalbio, Inc.
Decision Date1983-09-20
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INTUBATION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Calbio, Inc.. It received FDA 510(k) clearance on 1983-09-20 under 510(k) number K832629. 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 INTUBATION KIT?

INTUBATION KIT is a medical device that received FDA 510(k) clearance on 1983-09-20. The listed applicant is Calbio, Inc.. The 510(k) number is K832629.

When did INTUBATION KIT receive FDA 510(k) clearance?

INTUBATION KIT received FDA 510(k) clearance on 1983-09-20, under 510(k) number K832629.

Who is the listed applicant for INTUBATION KIT?

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

What is the FDA product code for INTUBATION KIT?

The FDA product code for INTUBATION KIT is BTR.

Related Clinical Trials

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.

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Other records listing Calbio, Inc. 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.

K813105PRESSURE INFUSION PUMP

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

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

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