FDA 510(k)

BreathID Hp Lab System

K号: K162150 · 2016-10-31

决定日期2016-10-31

产品代码MSQ

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决定实质等同

器械摘要

BreathID Hp Lab System is the device name listed in this FDA 510(k) record. The listed applicant is Exalenz Bioscience , Ltd.. It received FDA 510(k) clearance on 2016-10-31 under 510(k) number K162150. 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 Lab System?

BreathID Hp Lab System is a medical device that received FDA 510(k) clearance on 2016-10-31. The listed applicant is Exalenz Bioscience , Ltd.. The 510(k) number is K162150.

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

BreathID Hp Lab System received FDA 510(k) clearance on 2016-10-31, under 510(k) number K162150.

Who is the listed applicant for BreathID Hp Lab System?

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

What is the FDA product code for BreathID Hp Lab System?

The FDA product code for BreathID Hp Lab System is MSQ.

列明Exalenz Bioscience , 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。

K193610BreathID Smart System K173777BreathID Hp Lab System K173772BreathID Hp System

官方来源

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