FDA 510(k)

Harioculture TL-16 Time-lapse Incubator

K号: K242684 · 2025-05-22

决定日期2025-05-22

产品代码MQG

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决定实质等同

器械摘要

Harioculture TL-16 Time-lapse Incubator is the device name listed in this FDA 510(k) record. The listed applicant is Hua Yue Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-05-22 under 510(k) number K242684. The device is classified under product code MQG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Harioculture TL-16 Time-lapse Incubator?

Harioculture TL-16 Time-lapse Incubator is a medical device that received FDA 510(k) clearance on 2025-05-22. The listed applicant is Hua Yue Medical Technology Co., Ltd.. The 510(k) number is K242684.

When did Harioculture TL-16 Time-lapse Incubator receive FDA 510(k) clearance?

Harioculture TL-16 Time-lapse Incubator received FDA 510(k) clearance on 2025-05-22, under 510(k) number K242684.

Who is the listed applicant for Harioculture TL-16 Time-lapse Incubator?

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

What is the FDA product code for Harioculture TL-16 Time-lapse Incubator?

The FDA product code for Harioculture TL-16 Time-lapse Incubator is MQG.

列明Hua Yue Medical Technology 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。

K253333辅助生殖激光系统（型号ILS-400M）

相关器械（代码：MQG）

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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