FDA 510(k)

SmartAdjust technology

K号: K203774 · 2022-01-27

决定日期2022-01-27

产品代码QJI

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决定实质等同

器械摘要

SmartAdjust technology is the device name listed in this FDA 510(k) record. The listed applicant is Insulet Corporation. It received FDA 510(k) clearance on 2022-01-27 under 510(k) number K203774. The device is classified under product code QJI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SmartAdjust technology?

SmartAdjust technology is a medical device that received FDA 510(k) clearance on 2022-01-27. The listed applicant is Insulet Corporation. The 510(k) number is K203774.

When did SmartAdjust technology receive FDA 510(k) clearance?

SmartAdjust technology received FDA 510(k) clearance on 2022-01-27, under 510(k) number K203774.

Who is the listed applicant for SmartAdjust technology?

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

What is the FDA product code for SmartAdjust technology?

The FDA product code for SmartAdjust technology is QJI.

列明Insulet Corporation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。

K261461Omnipod 6 算法 K251779Omnipod 5 算法 K241777SmartAdjust™ 技术 K232741SmartAdjust™ 技术 K231824SmartBolus 计算器 K231826Omnipod 5 ACE 泵

查看所有 19 个设备 →

官方来源

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