FDA 510(k)

Huvitz 成像系统

K号: K191615 · 2019-07-18

决定日期2019-07-18

产品代码NFJ

咨询委员会RA

决定实质等同

器械摘要

Huvitz Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Huvitz Co., Ltd.. It received FDA 510(k) clearance on 2019-07-18 under 510(k) number K191615. The device is classified under product code NFJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Huvitz Imaging System?

Huvitz Imaging System is a medical device that received FDA 510(k) clearance on 2019-07-18. The listed applicant is Huvitz Co., Ltd.. The 510(k) number is K191615.

When did Huvitz Imaging System receive FDA 510(k) clearance?

Huvitz Imaging System received FDA 510(k) clearance on 2019-07-18, under 510(k) number K191615.

Who is the listed applicant for Huvitz Imaging System?

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

What is the FDA product code for Huvitz Imaging System?

The FDA product code for Huvitz Imaging System is NFJ.

列明Huvitz Co., 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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官方来源

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