FDA 510(k)

ABI 仪器，Creo 电外科系统

K号: K200298 · 2021-01-05

决定日期2021-01-05

产品代码NEY

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决定实质等同

器械摘要

ABI Instrument, Creo Electrosurgical System is the device name listed in this FDA 510(k) record. The listed applicant is Creo Medical, Ltd.. It received FDA 510(k) clearance on 2021-01-05 under 510(k) number K200298. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ABI Instrument, Creo Electrosurgical System?

ABI Instrument, Creo Electrosurgical System is a medical device that received FDA 510(k) clearance on 2021-01-05. The listed applicant is Creo Medical, Ltd.. The 510(k) number is K200298.

When did ABI Instrument, Creo Electrosurgical System receive FDA 510(k) clearance?

ABI Instrument, Creo Electrosurgical System received FDA 510(k) clearance on 2021-01-05, under 510(k) number K200298.

Who is the listed applicant for ABI Instrument, Creo Electrosurgical System?

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

What is the FDA product code for ABI Instrument, Creo Electrosurgical System?

The FDA product code for ABI Instrument, Creo Electrosurgical System is NEY.

列明Creo Medical, Ltd.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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相关器械（代码：NEY）

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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