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FDA 510(k)

Venner PneuX™ ETT（气管插管）6 mm，Venner PneuX™ ETT（气管插管）7 mm，Venner PneuX™ ETT（气管插管）8 mm，Venner PneuX™ ETT（气管插管）9 mm

K号: K192120 · 2020-02-14

申请人Venner Medical (Singapore) Pte, Ltd.
决定日期2020-02-14
产品代码BTR
咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
决定实质等同

器械摘要

Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mm is the device name listed in this FDA 510(k) record. The listed applicant is Venner Medical (Singapore) Pte, Ltd.. It received FDA 510(k) clearance on 2020-02-14 under 510(k) number K192120. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mm?

Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mm is a medical device that received FDA 510(k) clearance on 2020-02-14. The listed applicant is Venner Medical (Singapore) Pte, Ltd.. The 510(k) number is K192120.

When did Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mm receive FDA 510(k) clearance?

Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mm received FDA 510(k) clearance on 2020-02-14, under 510(k) number K192120.

Who is the listed applicant for Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mm?

The FDA 510(k) record lists Venner Medical (Singapore) Pte, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mm?

The FDA product code for Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mm is BTR.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Venner Medical (Singapore) Pte, Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K192511Venner PneuX™ TT（气管切开管）尺寸7.0毫米，Venner PneuX™ TT（气管切开管）尺寸8.0毫米，Venner PneuX™ TT（气管切开管）尺寸9.0毫米K191602APA 氧气刀

相关器械（代码：BTR）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K251794Tenax® 阻激光内窥镜气管导管Bryan Medical, Inc.K253437Spiro-VISTASpiro RoboticsK250173Shiley™ 口腔/鼻腔 RAE 气管导管无领，Murphy 眼 (113-XX) Shiley™ 鼻腔 RAE 气管导管无领，Murphy 眼 (114-XX) Shiley™ 口腔 RAE 气管导管带领，Murphy 眼 (115-XX) Shiley™ 口腔 RAE 气管导管带 TaperGuard™ Cuff，Murphy 眼 (115-XXOR) Shiley™ 鼻腔 RAE 气管导管带 TaperGuard™ Cuff，Murphy 眼 (119-XXNR)Covidien, LLCK243785Shiley™ 口腔/鼻腔气管导管带 TaperGuard™ Cuff 加强型，Murphy 眼 Shiley™ 气管导管 TaperGuard™ Cuff 加强型带芯 Shiley™ 低轮廓口腔/鼻腔气管导管带领加强型 Shiley™ 低轮廓口腔/鼻腔气管导管带领加强型，Murphy 眼 Shiley™ 口腔/鼻腔气管导管无领加强型Covidien, LLCK243579AeroJet 通气导管Pipeline Medical Products, LLCK251499Frova插管引导器（C-CAE-14.0-70-FII）；Frova插管引导器（C-CAE-14.0-70-FI）；Frova插管引导器（C-CAE-14.0-70-FIC）；Frova插管引导器（C-CAE-14.0-70-FIC-SPOPS）William Cook Europe Aps

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