FDA 510(k)

SPY Elite 手术室灌注评估系统

K号: K182907 · 2019-01-23

申请人Novadaq Technologies Ulc. (Now A Part of Stryker)

决定日期2019-01-23

产品代码IZI

咨询委员会RA

决定实质等同

器械摘要

SPY Elite Intraoperative Perfusion Assessment System is the device name listed in this FDA 510(k) record. The listed applicant is Novadaq Technologies Ulc. (Now A Part of Stryker). It received FDA 510(k) clearance on 2019-01-23 under 510(k) number K182907. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SPY Elite Intraoperative Perfusion Assessment System?

SPY Elite Intraoperative Perfusion Assessment System is a medical device that received FDA 510(k) clearance on 2019-01-23. The listed applicant is Novadaq Technologies Ulc. (Now A Part of Stryker). The 510(k) number is K182907.

When did SPY Elite Intraoperative Perfusion Assessment System receive FDA 510(k) clearance?

SPY Elite Intraoperative Perfusion Assessment System received FDA 510(k) clearance on 2019-01-23, under 510(k) number K182907.

Who is the listed applicant for SPY Elite Intraoperative Perfusion Assessment System?

The FDA 510(k) record lists Novadaq Technologies Ulc. (Now A Part of Stryker) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPY Elite Intraoperative Perfusion Assessment System?

The FDA product code for SPY Elite Intraoperative Perfusion Assessment System is IZI.

列明Novadaq Technologies Ulc. (Now A Part of Stryker)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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