FDA 510(k)

WAVICIDE-OPA MEC指示器

K号: K202565 · 2020-12-02

决定日期2020-12-02

产品代码JOJ

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。

决定实质等同

器械摘要

WAVICIDE-OPA MEC Indicator is the device name listed in this FDA 510(k) record. The listed applicant is Serim Research Corporation. It received FDA 510(k) clearance on 2020-12-02 under 510(k) number K202565. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the WAVICIDE-OPA MEC Indicator?

WAVICIDE-OPA MEC Indicator is a medical device that received FDA 510(k) clearance on 2020-12-02. The listed applicant is Serim Research Corporation. The 510(k) number is K202565.

When did WAVICIDE-OPA MEC Indicator receive FDA 510(k) clearance?

WAVICIDE-OPA MEC Indicator received FDA 510(k) clearance on 2020-12-02, under 510(k) number K202565.

Who is the listed applicant for WAVICIDE-OPA MEC Indicator?

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

What is the FDA product code for WAVICIDE-OPA MEC Indicator?

The FDA product code for WAVICIDE-OPA MEC Indicator is JOJ.

列明Serim Research Corporation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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相关器械（代码：JOJ）

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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