FDA 510(k)

Hemo Control（可选添加包Hemo Control DM）

K号: K200909 · 2020-06-12

决定日期2020-06-12

产品代码GKR

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决定实质等同

器械摘要

Hemo Control (optional Add Pack Hemo Control DM) is the device name listed in this FDA 510(k) record. The listed applicant is Ekf-Diagnostic GmbH. It received FDA 510(k) clearance on 2020-06-12 under 510(k) number K200909. 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 Hemo Control (optional Add Pack Hemo Control DM)?

Hemo Control (optional Add Pack Hemo Control DM) is a medical device that received FDA 510(k) clearance on 2020-06-12. The listed applicant is Ekf-Diagnostic GmbH. The 510(k) number is K200909.

When did Hemo Control (optional Add Pack Hemo Control DM) receive FDA 510(k) clearance?

Hemo Control (optional Add Pack Hemo Control DM) received FDA 510(k) clearance on 2020-06-12, under 510(k) number K200909.

Who is the listed applicant for Hemo Control (optional Add Pack Hemo Control DM)?

The FDA 510(k) record lists Ekf-Diagnostic GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hemo Control (optional Add Pack Hemo Control DM)?

The FDA product code for Hemo Control (optional Add Pack Hemo Control DM) is GKR.

列明Ekf-Diagnostic GmbH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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