FDA 510(k)

HemoCue Hb 801 系统

K号: K181751 · 2019-02-01

决定日期2019-02-01

产品代码GKR

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决定实质等同

器械摘要

HemoCue Hb 801 System is the device name listed in this FDA 510(k) record. The listed applicant is Hemocue AB. It received FDA 510(k) clearance on 2019-02-01 under 510(k) number K181751. The device is classified under product code GKR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the HemoCue Hb 801 System?

HemoCue Hb 801 System is a medical device that received FDA 510(k) clearance on 2019-02-01. The listed applicant is Hemocue AB. The 510(k) number is K181751.

When did HemoCue Hb 801 System receive FDA 510(k) clearance?

HemoCue Hb 801 System received FDA 510(k) clearance on 2019-02-01, under 510(k) number K181751.

Who is the listed applicant for HemoCue Hb 801 System?

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

What is the FDA product code for HemoCue Hb 801 System?

The FDA product code for HemoCue Hb 801 System is GKR.

列明Hemocue AB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。

K201217HemoCue Hb 301 系统

官方来源

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