FDA 510(k)

Pegasus System

K号: K191345 · 2019-07-17

决定日期2019-07-17

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

Pegasus System is the device name listed in this FDA 510(k) record. The listed applicant is A.M. Surgical, Inc.. It received FDA 510(k) clearance on 2019-07-17 under 510(k) number K191345. 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 Pegasus System?

Pegasus System is a medical device that received FDA 510(k) clearance on 2019-07-17. The listed applicant is A.M. Surgical, Inc.. The 510(k) number is K191345.

When did Pegasus System receive FDA 510(k) clearance?

Pegasus System received FDA 510(k) clearance on 2019-07-17, under 510(k) number K191345.

Who is the listed applicant for Pegasus System?

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

What is the FDA product code for Pegasus System?

The FDA product code for Pegasus System is HRX.

列明A.M. Surgical, 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。

K191771SECURE螺钉 K180087A.M. 手术髓内固定装置

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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