FDA 510(k)

ELEC 主机，ELEC 主机双

K号: K202963 · 2023-05-05

决定日期2023-05-05

产品代码EIA

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决定实质等同

器械摘要

ELEC Master, ELEC Master Dual is the device name listed in this FDA 510(k) record. The listed applicant is Mgnewton , Ltd.. It received FDA 510(k) clearance on 2023-05-05 under 510(k) number K202963. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ELEC Master, ELEC Master Dual?

ELEC Master, ELEC Master Dual is a medical device that received FDA 510(k) clearance on 2023-05-05. The listed applicant is Mgnewton , Ltd.. The 510(k) number is K202963.

When did ELEC Master, ELEC Master Dual receive FDA 510(k) clearance?

ELEC Master, ELEC Master Dual received FDA 510(k) clearance on 2023-05-05, under 510(k) number K202963.

Who is the listed applicant for ELEC Master, ELEC Master Dual?

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

What is the FDA product code for ELEC Master, ELEC Master Dual?

The FDA product code for ELEC Master, ELEC Master Dual is EIA.

列明Mgnewton , 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。

K202965CURA-Temp

官方来源

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