FDA 510(k)

EVE 协同（EVE-20M）

K号: K241433 · 2025-06-04

决定日期2025-06-04

产品代码IPF

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决定实质等同

器械摘要

EVE Synergy (EVE-20M) 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 2025-06-04 under 510(k) number K241433. 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 EVE Synergy (EVE-20M)?

EVE Synergy (EVE-20M) is a medical device that received FDA 510(k) clearance on 2025-06-04. The listed applicant is Weero Co., Ltd.. The 510(k) number is K241433.

When did EVE Synergy (EVE-20M) receive FDA 510(k) clearance?

EVE Synergy (EVE-20M) received FDA 510(k) clearance on 2025-06-04, under 510(k) number K241433.

Who is the listed applicant for EVE Synergy (EVE-20M)?

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 EVE Synergy (EVE-20M)?

The FDA product code for EVE Synergy (EVE-20M) 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）K240992eMVFit（MVF-10M）K240991eMVFit（MVF-10M）

官方来源

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