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FDA 510(k)

ART-Plan+ (v3.1.0)

K号: K253091 · 2025-12-23

决定日期2025-12-23
产品代码MUJ
咨询委员会RA
决定实质等同

器械摘要

ART-Plan+ (v3.1.0) is the device name listed in this FDA 510(k) record. The listed applicant is Therapanacea Sas. It received FDA 510(k) clearance on 2025-12-23 under 510(k) number K253091. The device is classified under product code MUJ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ART-Plan+ (v3.1.0)?

ART-Plan+ (v3.1.0) is a medical device that received FDA 510(k) clearance on 2025-12-23. The listed applicant is Therapanacea Sas. The 510(k) number is K253091.

When did ART-Plan+ (v3.1.0) receive FDA 510(k) clearance?

ART-Plan+ (v3.1.0) received FDA 510(k) clearance on 2025-12-23, under 510(k) number K253091.

Who is the listed applicant for ART-Plan+ (v3.1.0)?

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

What is the FDA product code for ART-Plan+ (v3.1.0)?

The FDA product code for ART-Plan+ (v3.1.0) is MUJ.

列明Therapanacea Sas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。

相关器械(代码:MUJ)

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。

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息,请务必参考官方记录。

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