FDA 510(k)

twiist 自动胰岛素输送（AID）系统

K号: K261672 · 2026-06-17

决定日期2026-06-17

产品代码QFG

咨询委员会CH 请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

twiist Automated Insulin Delivery (AID) System 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 2026-06-17 under 510(k) number K261672. The device is classified under product code QFG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the twiist Automated Insulin Delivery (AID) System?

twiist Automated Insulin Delivery (AID) System is a medical device that received FDA 510(k) clearance on 2026-06-17. The listed applicant is Deka Research and Development. The 510(k) number is K261672.

When did twiist Automated Insulin Delivery (AID) System receive FDA 510(k) clearance?

twiist Automated Insulin Delivery (AID) System received FDA 510(k) clearance on 2026-06-17, under 510(k) number K261672.

Who is the listed applicant for twiist Automated Insulin Delivery (AID) System?

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 twiist Automated Insulin Delivery (AID) System?

The FDA product code for twiist Automated Insulin Delivery (AID) System is QFG.

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。

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 K241178DEKA ACE 泵系统

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。