FDA 510(k)

KET-1血酮监测系统

K号: K182593 · 2018-12-18

决定日期2018-12-18

产品代码JIN

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决定实质等同

器械摘要

KET-1 Blood Ketone Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Apex BioTechnology Corp.. It received FDA 510(k) clearance on 2018-12-18 under 510(k) number K182593. The device is classified under product code JIN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the KET-1 Blood Ketone Monitoring System?

KET-1 Blood Ketone Monitoring System is a medical device that received FDA 510(k) clearance on 2018-12-18. The listed applicant is Apex BioTechnology Corp.. The 510(k) number is K182593.

When did KET-1 Blood Ketone Monitoring System receive FDA 510(k) clearance?

KET-1 Blood Ketone Monitoring System received FDA 510(k) clearance on 2018-12-18, under 510(k) number K182593.

Who is the listed applicant for KET-1 Blood Ketone Monitoring System?

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

What is the FDA product code for KET-1 Blood Ketone Monitoring System?

The FDA product code for KET-1 Blood Ketone Monitoring System is JIN.

列明Apex BioTechnology Corp.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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官方来源

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