FDA 510(k)

Solo, Swing Maxi

K号: K210759 · 2021-08-11

决定日期2021-08-11

产品代码HGX

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决定实质等同

器械摘要

Solo, Swing Maxi is the device name listed in this FDA 510(k) record. The listed applicant is Medela, LLC. It received FDA 510(k) clearance on 2021-08-11 under 510(k) number K210759. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Solo, Swing Maxi?

Solo, Swing Maxi is a medical device that received FDA 510(k) clearance on 2021-08-11. The listed applicant is Medela, LLC. The 510(k) number is K210759.

When did Solo, Swing Maxi receive FDA 510(k) clearance?

Solo, Swing Maxi received FDA 510(k) clearance on 2021-08-11, under 510(k) number K210759.

Who is the listed applicant for Solo, Swing Maxi?

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

What is the FDA product code for Solo, Swing Maxi?

The FDA product code for Solo, Swing Maxi is HGX.

列明Medela, LLC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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相关器械（代码：HGX）

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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