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FDA 510(k)

Stryker T7 外科帽，Stryker T7 外科袍，拉链式，Stryker T7 外科袍，带可撕除面部防护罩的拉链式，Stryker T7 外科袍，套头式

K号: K200493 · 2020-03-21

申请人Stryker Corporation
决定日期2020-03-21
产品代码FXY
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation. It received FDA 510(k) clearance on 2020-03-21 under 510(k) number K200493. The device is classified under product code FXY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover?

Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover is a medical device that received FDA 510(k) clearance on 2020-03-21. The listed applicant is Stryker Corporation. The 510(k) number is K200493.

When did Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover receive FDA 510(k) clearance?

Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover received FDA 510(k) clearance on 2020-03-21, under 510(k) number K200493.

Who is the listed applicant for Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover?

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

What is the FDA product code for Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover?

The FDA product code for Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover is FXY.

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Stryker Corporation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。

K232157带有设备和语音控制的连接手术室中心，SDC4K信息管理系统K223770Sonopet 1Q 3 7cm 1Q LargeK212194Stryker Q引导系统及颅骨引导软件，CranialMask追踪器和显微镜追踪器，被动光学导航仪器，Mayfield底座带活动臂，导航活检针，电磁导航仪器，精确靶向系统K221728Aviator® 前颈椎板（ACP）系统，LITe® 板系统，DynaTran™ 前颈椎板（ACP）系统，Reflex™ 混合ACP系统，UniVise™ 椎板固定板系统K221074OptaBlate RF 发生器，OptaBlate 探头，OptaBlate 微注射注射装置K221098Scopis ENT软件，Scopis ENT软件带TGS，Scopis规划软件，电磁导航单元

查看所有 42 个设备 →

相关器械（代码：FXY）

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。

K222214ViVi® 手术头盔系统（ViVi® 头盔，ViVi® 头盔 HPL，ViVi® 头罩）Thi Total Healthcare Innovation GmbH

官方来源

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