FDA 510(k)

STOP U 型 UXV 设备

K号: K203665 · 2021-02-25

决定日期2021-02-25

产品代码PAY

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决定实质等同

器械摘要

STOP U Model UXV Device is the device name listed in this FDA 510(k) record. The listed applicant is Pollogen, Ltd.. It received FDA 510(k) clearance on 2021-02-25 under 510(k) number K203665. The device is classified under product code PAY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the STOP U Model UXV Device?

STOP U Model UXV Device is a medical device that received FDA 510(k) clearance on 2021-02-25. The listed applicant is Pollogen, Ltd.. The 510(k) number is K203665.

When did STOP U Model UXV Device receive FDA 510(k) clearance?

STOP U Model UXV Device received FDA 510(k) clearance on 2021-02-25, under 510(k) number K203665.

Who is the listed applicant for STOP U Model UXV Device?

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

What is the FDA product code for STOP U Model UXV Device?

The FDA product code for STOP U Model UXV Device is PAY.

列明Pollogen, 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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