FDA 510(k)

STERIZONE VP4 测试包

K号: K203560 · 2021-03-24

决定日期2021-03-24

产品代码FRC

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

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器械摘要

STERIZONE VP4 Test Pack is the device name listed in this FDA 510(k) record. The listed applicant is Tso3 Inc., Now A Part of Stryker. It received FDA 510(k) clearance on 2021-03-24 under 510(k) number K203560. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the STERIZONE VP4 Test Pack?

STERIZONE VP4 Test Pack is a medical device that received FDA 510(k) clearance on 2021-03-24. The listed applicant is Tso3 Inc., Now A Part of Stryker. The 510(k) number is K203560.

When did STERIZONE VP4 Test Pack receive FDA 510(k) clearance?

STERIZONE VP4 Test Pack received FDA 510(k) clearance on 2021-03-24, under 510(k) number K203560.

Who is the listed applicant for STERIZONE VP4 Test Pack?

The FDA 510(k) record lists Tso3 Inc., Now A Part of Stryker as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERIZONE VP4 Test Pack?

The FDA product code for STERIZONE VP4 Test Pack is FRC.

相关器械（代码：FRC）

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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器械摘要

常见问题

相关临床试验

相关器械（代码：FRC）

官方来源