FDA 510(k)

Perifit Care+

K号: K231780 · 2023-12-20

决定日期2023-12-20

产品代码HIR

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决定实质等同

器械摘要

Perifit Care+ is the device name listed in this FDA 510(k) record. The listed applicant is X6 Innovations. It received FDA 510(k) clearance on 2023-12-20 under 510(k) number K231780. The device is classified under product code HIR. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Perifit Care+?

Perifit Care+ is a medical device that received FDA 510(k) clearance on 2023-12-20. The listed applicant is X6 Innovations. The 510(k) number is K231780.

When did Perifit Care+ receive FDA 510(k) clearance?

Perifit Care+ received FDA 510(k) clearance on 2023-12-20, under 510(k) number K231780.

Who is the listed applicant for Perifit Care+?

The FDA 510(k) record lists X6 Innovations as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Perifit Care+?

The FDA product code for Perifit Care+ is HIR.

列明X6 Innovations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。

K231785Perifit 泵 K221476Perifit

官方来源

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