FDA 510(k)

Mick Valencia 施用器套装

K号: K230155 · 2023-08-30

决定日期2023-08-30

产品代码JAQ

咨询委员会RA

决定实质等同

器械摘要

Mick Valencia Applicator Set is the device name listed in this FDA 510(k) record. The listed applicant is Mick Radio-Nuclear Instruments, Inc.. It received FDA 510(k) clearance on 2023-08-30 under 510(k) number K230155. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Mick Valencia Applicator Set?

Mick Valencia Applicator Set is a medical device that received FDA 510(k) clearance on 2023-08-30. The listed applicant is Mick Radio-Nuclear Instruments, Inc.. The 510(k) number is K230155.

When did Mick Valencia Applicator Set receive FDA 510(k) clearance?

Mick Valencia Applicator Set received FDA 510(k) clearance on 2023-08-30, under 510(k) number K230155.

Who is the listed applicant for Mick Valencia Applicator Set?

The FDA 510(k) record lists Mick Radio-Nuclear Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mick Valencia Applicator Set?

The FDA product code for Mick Valencia Applicator Set is JAQ.

列明Mick Radio-Nuclear Instruments, Inc.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。

K200221CT F/S/D兼容应用器（Fletcher），HDR兼容串联和椭圆形应用器（Henschke），HDR CT兼容分裂环应用器，分段阴道应用器，HDR迈阿密应用器HDR近距离放射治疗应用器，2/3子宫内膜应用器套装，CT HDR环和串联应用器带直肠拉钩 K150979CT/MR 兼容 M.A.C. 间质性妇科模板

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。