FDA 510(k)

SIS 系统

K号: K230977 · 2023-05-02

决定日期2023-05-02

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

SIS System is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Information Sciences, Inc.. It received FDA 510(k) clearance on 2023-05-02 under 510(k) number K230977. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SIS System?

SIS System is a medical device that received FDA 510(k) clearance on 2023-05-02. The listed applicant is Surgical Information Sciences, Inc.. The 510(k) number is K230977.

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

SIS System received FDA 510(k) clearance on 2023-05-02, under 510(k) number K230977.

Who is the listed applicant for SIS System?

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

What is the FDA product code for SIS System?

The FDA product code for SIS System is QIH.

列明Surgical Information 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。

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官方来源

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