FDA 510(k)

Tandem Mobi 胰岛素泵，具有互操作性技术

K号: K223213 · 2023-07-10

决定日期2023-07-10

产品代码QFG

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决定实质等同

器械摘要

Tandem Mobi Insulin Pump with Interoperable Technology is the device name listed in this FDA 510(k) record. The listed applicant is Tandem Diabetes Care, Inc.. It received FDA 510(k) clearance on 2023-07-10 under 510(k) number K223213. 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 Tandem Mobi Insulin Pump with Interoperable Technology?

Tandem Mobi Insulin Pump with Interoperable Technology is a medical device that received FDA 510(k) clearance on 2023-07-10. The listed applicant is Tandem Diabetes Care, Inc.. The 510(k) number is K223213.

When did Tandem Mobi Insulin Pump with Interoperable Technology receive FDA 510(k) clearance?

Tandem Mobi Insulin Pump with Interoperable Technology received FDA 510(k) clearance on 2023-07-10, under 510(k) number K223213.

Who is the listed applicant for Tandem Mobi Insulin Pump with Interoperable Technology?

The FDA 510(k) record lists Tandem Diabetes Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tandem Mobi Insulin Pump with Interoperable Technology?

The FDA product code for Tandem Mobi Insulin Pump with Interoperable Technology is QFG.

列明Tandem Diabetes Care, 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。

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