FDA 510(k)

PEDIATRIC ENDOTRACHEAL TUBE

K-Number: K951697 · 1995-05-22

Decision Date1995-05-22

Product CodeBTR

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

PEDIATRIC ENDOTRACHEAL TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Unomedical Sdn Bhd. It received FDA 510(k) clearance on 1995-05-22 under 510(k) number K951697. 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 PEDIATRIC ENDOTRACHEAL TUBE?

PEDIATRIC ENDOTRACHEAL TUBE is a medical device that received FDA 510(k) clearance on 1995-05-22. The listed applicant is Unomedical Sdn Bhd. The 510(k) number is K951697.

When did PEDIATRIC ENDOTRACHEAL TUBE receive FDA 510(k) clearance?

PEDIATRIC ENDOTRACHEAL TUBE received FDA 510(k) clearance on 1995-05-22, under 510(k) number K951697.

Who is the listed applicant for PEDIATRIC ENDOTRACHEAL TUBE?

The FDA 510(k) record lists Unomedical Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PEDIATRIC ENDOTRACHEAL TUBE?

The FDA product code for PEDIATRIC ENDOTRACHEAL TUBE is BTR.

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Other records listing Unomedical Sdn Bhd as applicant

K973076EUROMEDICAL HAEMATURIA FOLEY CATHETER K962389EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE K954750PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE K954751SILICONE ENDOTRACHEAL TUBE K954754WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE K954753PEDIATRIC SILICONE ENDOTRACHEAL TUBE

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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.