FDA 510(k)

OMNI PLUS Surgical System

K号: K201953 · 2020-08-11

决定日期2020-08-11

产品代码MRH

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

OMNI PLUS Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is Sight Sciences, Inc.. It received FDA 510(k) clearance on 2020-08-11 under 510(k) number K201953. The device is classified under product code MRH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the OMNI PLUS Surgical System?

OMNI PLUS Surgical System is a medical device that received FDA 510(k) clearance on 2020-08-11. The listed applicant is Sight Sciences, Inc.. The 510(k) number is K201953.

When did OMNI PLUS Surgical System receive FDA 510(k) clearance?

OMNI PLUS Surgical System received FDA 510(k) clearance on 2020-08-11, under 510(k) number K201953.

Who is the listed applicant for OMNI PLUS Surgical System?

FDA 510(k)记录中列出Sight Sciences, Inc.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for OMNI PLUS Surgical System?

The FDA product code for OMNI PLUS Surgical System is MRH.

列明Sight Sciences, 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。

K262479TearCare 系统 K253760OMNI超手术系统（1-110）K252409TearCare MGX 系统泪液护理系统 K242786TearCare MGX 系统泪液护理系统 K231084TearCare MGX 系统泪液护理系统 K232214OMNI Surgical System

查看所有 11 个设备 →

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。