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FDA 510(k)

PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE

K-Number: K100546 · 2010-06-03

ApplicantParkermedicalinc
Decision Date2010-06-03
Product CodeBTR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Parkermedicalinc. It received FDA 510(k) clearance on 2010-06-03 under 510(k) number K100546. 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 PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE?

PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE is a medical device that received FDA 510(k) clearance on 2010-06-03. The listed applicant is Parkermedicalinc. The 510(k) number is K100546.

When did PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE receive FDA 510(k) clearance?

PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE received FDA 510(k) clearance on 2010-06-03, under 510(k) number K100546.

Who is the listed applicant for PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE?

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

What is the FDA product code for PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE?

The FDA product code for PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE is BTR.

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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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