FDA 510(k)

RAPID Web

K号: K170839 · 2017-05-26

决定日期2017-05-26

产品代码NEZ

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

RAPID Web is the device name listed in this FDA 510(k) record. The listed applicant is Given Imaging , Ltd.. It received FDA 510(k) clearance on 2017-05-26 under 510(k) number K170839. The device is classified under product code NEZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the RAPID Web?

RAPID Web is a medical device that received FDA 510(k) clearance on 2017-05-26. The listed applicant is Given Imaging , Ltd.. The 510(k) number is K170839.

When did RAPID Web receive FDA 510(k) clearance?

RAPID Web received FDA 510(k) clearance on 2017-05-26, under 510(k) number K170839.

Who is the listed applicant for RAPID Web?

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

What is the FDA product code for RAPID Web?

The FDA product code for RAPID Web is NEZ.

列明Given Imaging , 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。

K180171PillCam 透导系统 K170210PillCam SBC 胶囊内镜系统，PilCam 桌面软件 9.0 K151086ManoScan System K153466PillCam COLON 2 胶囊内镜系统

相关器械（代码：NEZ）

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。

K252617MiroCam® 纤维内窥镜系统Intromedic Co., Ltd.K252480CE Deliver (DLV)CapsoVision, Inc.K242643CapsoCam Plus (SV-3) 球囊内镜系统CapsoVision, Inc.K240276PillCam™ Genius SB 系统，配备 PillCam 软件 v9.7 和 PillCam Cloud Reader 软件Given Imaging Ltd. (D.B.A. Medtronic)K233229NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam TetherAnx Robotica Corporation K230991PillCam SB 3 胶囊内镜系统，PillCam 软件 9.0EGiven Imaging Ltd. (Medtronic)

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