FDA 510(k)

eMVFit（MVF-10M）

K号: K240992 · 2024-10-10

决定日期2024-10-10

产品代码IPF

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决定实质等同

器械摘要

eMVFit (MVF-10M) is the device name listed in this FDA 510(k) record. The listed applicant is Weero Co., Ltd.. It received FDA 510(k) clearance on 2024-10-10 under 510(k) number K240992. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the eMVFit (MVF-10M)?

eMVFit (MVF-10M) is a medical device that received FDA 510(k) clearance on 2024-10-10. The listed applicant is Weero Co., Ltd.. The 510(k) number is K240992.

When did eMVFit (MVF-10M) receive FDA 510(k) clearance?

eMVFit (MVF-10M) received FDA 510(k) clearance on 2024-10-10, under 510(k) number K240992.

Who is the listed applicant for eMVFit (MVF-10M)?

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

What is the FDA product code for eMVFit (MVF-10M)?

The FDA product code for eMVFit (MVF-10M) is IPF.

列明Weero 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。

K253542Apollo Quattro（APQ-10M）K253261Apollo Quattro（APQ-10M）K241433EVE 协同（EVE-20M）K240991eMVFit（MVF-10M）

官方来源

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