FDA 510(k)

Endotracheal Tube

Número K: K190274 · 2019-07-30

RequerenteTianjin Medis Medical Device Co., Ltd.

Data da decisão2019-07-30

Código do produtoBTR

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Endotracheal Tube is the device name listed in this FDA 510(k) record. The listed applicant is Tianjin Medis Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2019-07-30 under 510(k) number K190274. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Endotracheal Tube?

Endotracheal Tube is a medical device that received FDA 510(k) clearance on 2019-07-30. The listed applicant is Tianjin Medis Medical Device Co., Ltd.. The 510(k) number is K190274.

When did Endotracheal Tube receive FDA 510(k) clearance?

Endotracheal Tube received FDA 510(k) clearance on 2019-07-30, under 510(k) number K190274.

Who is the listed applicant for Endotracheal Tube?

The FDA 510(k) record lists Tianjin Medis Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endotracheal Tube?

The FDA product code for Endotracheal Tube is BTR.

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Outros registros que listam Tianjin Medis Medical Device Co., Ltd. como candidato(a)

K182548Indicador de Pressão Accucuff K160694Disposable Endotracheal tube, sterile, AccuCuff

Dispositivos Relacionados (Código: 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 K243579Cáteter de Ventilação AeroJetPipeline 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

Fonte oficial

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