FDA 510(k)

DEKA 注射系统，DEKA 管理套装

K号: K232316 · 2024-03-01

决定日期2024-03-01

产品代码LDR

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

DEKA Infusion System, DEKA Administration Set is the device name listed in this FDA 510(k) record. The listed applicant is Deka Research and Development. It received FDA 510(k) clearance on 2024-03-01 under 510(k) number K232316. The device is classified under product code LDR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DEKA Infusion System, DEKA Administration Set?

DEKA Infusion System, DEKA Administration Set is a medical device that received FDA 510(k) clearance on 2024-03-01. The listed applicant is Deka Research and Development. The 510(k) number is K232316.

When did DEKA Infusion System, DEKA Administration Set receive FDA 510(k) clearance?

DEKA Infusion System, DEKA Administration Set received FDA 510(k) clearance on 2024-03-01, under 510(k) number K232316.

Who is the listed applicant for DEKA Infusion System, DEKA Administration Set?

The FDA 510(k) record lists Deka Research and Development as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEKA Infusion System, DEKA Administration Set?

The FDA product code for DEKA Infusion System, DEKA Administration Set is LDR.

列明Deka Research and Development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。

K261672twiist 自动胰岛素输送（AID）系统 K261530iiSure 静脉输液器 K243841Sparta 胰岛素输液器 K240920HemoCare 碳酸氢钠浓缩液套装（BCS）K233557HemoCare 血液透析系统 K240256Remunity 系统

查看所有 15 个设备 →

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。