FDA 510(k)

CMDR 2ST (多种型号)，CMDR 2SPE (多种型号)，Integris

K号: K171353 · 2017-06-07

决定日期2017-06-07

产品代码IZL

咨询委员会RA

决定实质等同

器械摘要

CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris is the device name listed in this FDA 510(k) record. The listed applicant is Minxray, Inc.. It received FDA 510(k) clearance on 2017-06-07 under 510(k) number K171353. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris?

CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris is a medical device that received FDA 510(k) clearance on 2017-06-07. The listed applicant is Minxray, Inc.. The 510(k) number is K171353.

When did CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris receive FDA 510(k) clearance?

CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris received FDA 510(k) clearance on 2017-06-07, under 510(k) number K171353.

Who is the listed applicant for CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris?

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

What is the FDA product code for CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris?

The FDA product code for CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), Integris is IZL.

列明Minxray, 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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