FDA 510(k)

GUEDEL AIRWAYS

K-Number: K932561 · 1993-07-22

ApplicantLife Shield Healthcare Products, Inc.

Decision Date1993-07-22

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

GUEDEL AIRWAYS is the device name listed in this FDA 510(k) record. The listed applicant is Life Shield Healthcare Products, Inc.. It received FDA 510(k) clearance on 1993-07-22 under 510(k) number K932561. 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 GUEDEL AIRWAYS?

GUEDEL AIRWAYS is a medical device that received FDA 510(k) clearance on 1993-07-22. The listed applicant is Life Shield Healthcare Products, Inc.. The 510(k) number is K932561.

When did GUEDEL AIRWAYS receive FDA 510(k) clearance?

GUEDEL AIRWAYS received FDA 510(k) clearance on 1993-07-22, under 510(k) number K932561.

Who is the listed applicant for GUEDEL AIRWAYS?

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

What is the FDA product code for GUEDEL AIRWAYS?

The FDA product code for GUEDEL AIRWAYS is BTR.

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Other records listing Life Shield Healthcare Products, Inc. as applicant

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Related Devices (Code: BTR)

K251794Tenax® Laser Resistant Endotracheal TubeBryan Medical, Inc.K253437Spiro-VISTASpiro Robotics K250173Shiley™ 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, LLC K243785Shiley™ 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, LLC K243579AeroJet Ventilation CatheterPipeline Medical Products, LLC K251499Frova 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.