FDA 510(k)

GENEO X ELITE

K号: K242227 · 2025-10-12

决定日期2025-10-12

产品代码PAY

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决定实质等同

器械摘要

GENEO X ELITE is the device name listed in this FDA 510(k) record. The listed applicant is Pollogen, Ltd.. It received FDA 510(k) clearance on 2025-10-12 under 510(k) number K242227. 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 GENEO X ELITE?

GENEO X ELITE is a medical device that received FDA 510(k) clearance on 2025-10-12. The listed applicant is Pollogen, Ltd.. The 510(k) number is K242227.

When did GENEO X ELITE receive FDA 510(k) clearance?

GENEO X ELITE received FDA 510(k) clearance on 2025-10-12, under 510(k) number K242227.

Who is the listed applicant for GENEO X ELITE?

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 GENEO X ELITE?

The FDA product code for GENEO X ELITE 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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