FDA 510(k)

SmartBolus 计算器

K号: K222239 · 2022-08-19

决定日期2022-08-19

产品代码QRX

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决定实质等同

器械摘要

SmartBolus Calculator is the device name listed in this FDA 510(k) record. The listed applicant is Insulet Corporation. It received FDA 510(k) clearance on 2022-08-19 under 510(k) number K222239. The device is classified under product code QRX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SmartBolus Calculator?

SmartBolus Calculator is a medical device that received FDA 510(k) clearance on 2022-08-19. The listed applicant is Insulet Corporation. The 510(k) number is K222239.

When did SmartBolus Calculator receive FDA 510(k) clearance?

SmartBolus Calculator received FDA 510(k) clearance on 2022-08-19, under 510(k) number K222239.

Who is the listed applicant for SmartBolus Calculator?

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 SmartBolus Calculator?

The FDA product code for SmartBolus Calculator is QRX.

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。

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官方来源

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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。