FDA 510(k)

Capenergy C 设备 RF C200 和 C400 Drakarian

K号: K253480 · 2026-07-10

决定日期2026-07-10

产品代码PBX

咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。

决定实质等同

器械摘要

Capenergy C Equipments RF C200 and C400 Drakarian is the device name listed in this FDA 510(k) record. The listed applicant is Capenergy Medical S.L.. It received FDA 510(k) clearance on 2026-07-10 under 510(k) number K253480. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Capenergy C Equipments RF C200 and C400 Drakarian?

Capenergy C Equipments RF C200 and C400 Drakarian is a medical device that received FDA 510(k) clearance on 2026-07-10. The listed applicant is Capenergy Medical S.L.. The 510(k) number is K253480.

When did Capenergy C Equipments RF C200 and C400 Drakarian receive FDA 510(k) clearance?

Capenergy C Equipments RF C200 and C400 Drakarian received FDA 510(k) clearance on 2026-07-10, under 510(k) number K253480.

Who is the listed applicant for Capenergy C Equipments RF C200 and C400 Drakarian?

The FDA 510(k) record lists Capenergy Medical S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Capenergy C Equipments RF C200 and C400 Drakarian?

The FDA product code for Capenergy C Equipments RF C200 and C400 Drakarian is PBX.

列明Capenergy Medical S.L.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。

K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 K191202CAPENERGY - C100, C200, C300, C400, C50

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。