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FDA 510(k)

空气压缩腿部按摩器(MM0520,MM0521,MM0522)

K号: K222443 · 2023-08-09

决定日期2023-08-09
产品代码BZG
咨询委员会AN 请注意,由于您没有提供完整的医疗设备监管文本,我无法提供完整的翻译。如果您能提供完整的文本,我将很乐意为您翻译。
决定实质等同

器械摘要

Air Smart Extra Spirometer is the device name listed in this FDA 510(k) record. The listed applicant is Feellife Health, Inc.. It received FDA 510(k) clearance on 2023-08-09 under 510(k) number K222443. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Air Smart Extra Spirometer?

Air Smart Extra Spirometer is a medical device that received FDA 510(k) clearance on 2023-08-09. The listed applicant is Feellife Health, Inc.. The 510(k) number is K222443.

When did Air Smart Extra Spirometer receive FDA 510(k) clearance?

Air Smart Extra Spirometer received FDA 510(k) clearance on 2023-08-09, under 510(k) number K222443.

Who is the listed applicant for Air Smart Extra Spirometer?

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

What is the FDA product code for Air Smart Extra Spirometer?

The FDA product code for Air Smart Extra Spirometer is BZG.

相关临床试验

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列明Feellife Health, 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。

相关器械(代码:BZG)

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。

官方来源

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