FDA 510(k)

Steripath Gen2 血液采集系统

K号: K192247 · 2020-02-28

决定日期2020-02-28

产品代码JKA

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决定实质等同

器械摘要

Steripath Gen2 Blood Collection System is the device name listed in this FDA 510(k) record. The listed applicant is Magnolia Medical Technologies, Inc.. It received FDA 510(k) clearance on 2020-02-28 under 510(k) number K192247. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Steripath Gen2 Blood Collection System?

Steripath Gen2 Blood Collection System is a medical device that received FDA 510(k) clearance on 2020-02-28. The listed applicant is Magnolia Medical Technologies, Inc.. The 510(k) number is K192247.

When did Steripath Gen2 Blood Collection System receive FDA 510(k) clearance?

Steripath Gen2 Blood Collection System received FDA 510(k) clearance on 2020-02-28, under 510(k) number K192247.

Who is the listed applicant for Steripath Gen2 Blood Collection System?

The FDA 510(k) record lists Magnolia Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Steripath Gen2 Blood Collection System?

The FDA product code for Steripath Gen2 Blood Collection System is JKA.

列明Magnolia Medical Technologies, Inc.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。

K200661Steripath 微型血液采集系统

相关器械（代码：JKA）

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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