FDA 510(k)

MIDAScope 和引入器套件，以及 MIDASystem

K号: K181982 · 2018-08-21

决定日期2018-08-21

产品代码HRX

咨询委员会OR 请注意，由于原文中未提供具体的医疗设备监管文本，以下是一个示例翻译，您可以根据实际文本进行调整： --- 产品名称：[产品名称] 公司名称：[公司名称] 根据FDA 510(k)预市场批准程序，[产品名称]已获得批准，用于[产品用途描述]。产品注册号：[注册号] PMA编号：[PMA编号] 临床试验编号（NCT）：[NCT编号] PubMed ID（PMID）：[PMID编号] 更多信息请访问以下链接： [URL] --- 请将上述示例中的[产品名称]、[公司名称]、[注册号]、[PMA编号]、[NCT编号]、[PMID编号]和[URL]替换为实际的文本内容。

决定实质等同

器械摘要

MIDAScope and Introducer Kit, and MIDASystem is the device name listed in this FDA 510(k) record. The listed applicant is Intravu, Inc.. It received FDA 510(k) clearance on 2018-08-21 under 510(k) number K181982. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MIDAScope and Introducer Kit, and MIDASystem?

MIDAScope and Introducer Kit, and MIDASystem is a medical device that received FDA 510(k) clearance on 2018-08-21. The listed applicant is Intravu, Inc.. The 510(k) number is K181982.

When did MIDAScope and Introducer Kit, and MIDASystem receive FDA 510(k) clearance?

MIDAScope and Introducer Kit, and MIDASystem received FDA 510(k) clearance on 2018-08-21, under 510(k) number K181982.

Who is the listed applicant for MIDAScope and Introducer Kit, and MIDASystem?

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

What is the FDA product code for MIDAScope and Introducer Kit, and MIDASystem?

The FDA product code for MIDAScope and Introducer Kit, and MIDASystem is HRX.

列明Intravu, Inc.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。

K243020MIDASVu

相关器械（代码：HRX）

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。

K260203富勒椎体成形术球囊导管Beijing Fule Science & Technology Development Co., Ltd.K254103霍普金斯关节镜望远镜Karl Storz SE & CO. KG K252790数字ClarusScope系统及数字NeuroPEN系统Clarus Medical, LLC K253523Freedom DS®减压系统Spinal Simplicity K252546Vantage™ 腰椎减压套装Allevion Medical, LLC K253217MiiS Horus 眼镜镜片（EJA 100）；MiiS Horus 内窥镜显示系统 - 平板（EDS 500）；MiiS Horus 内窥镜显示系统 - 视频盒（EVS 700）Medimaging Integrated Solution, Inc (Miis)

官方来源

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