FDA 510(k)

BreathID Hp System

K号: K221896 · 2022-12-19

决定日期2022-12-19

产品代码MSQ

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决定实质等同

器械摘要

BreathID Hp System is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Bioscience Israel , Ltd.. It received FDA 510(k) clearance on 2022-12-19 under 510(k) number K221896. The device is classified under product code MSQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BreathID Hp System?

BreathID Hp System is a medical device that received FDA 510(k) clearance on 2022-12-19. The listed applicant is Meridian Bioscience Israel , Ltd.. The 510(k) number is K221896.

When did BreathID Hp System receive FDA 510(k) clearance?

BreathID Hp System received FDA 510(k) clearance on 2022-12-19, under 510(k) number K221896.

Who is the listed applicant for BreathID Hp System?

The FDA 510(k) record lists Meridian Bioscience Israel , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BreathID Hp System?

The FDA product code for BreathID Hp System is MSQ.

列明Meridian Bioscience Israel , Ltd.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。

K223185BreathID® Smart System K220494BreathID Hp Lab System, BreathID Smart System

官方来源

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