FDA 510(k)

OK Plus 指示器

K号: K222137 · 2022-12-05

决定日期2022-12-05

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

OK Plus Indicator is the device name listed in this FDA 510(k) record. The listed applicant is Propper Manufacturing Co., Inc.. It received FDA 510(k) clearance on 2022-12-05 under 510(k) number K222137. 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 OK Plus Indicator?

OK Plus Indicator is a medical device that received FDA 510(k) clearance on 2022-12-05. The listed applicant is Propper Manufacturing Co., Inc.. The 510(k) number is K222137.

When did OK Plus Indicator receive FDA 510(k) clearance?

OK Plus Indicator received FDA 510(k) clearance on 2022-12-05, under 510(k) number K222137.

Who is the listed applicant for OK Plus Indicator?

The FDA 510(k) record lists Propper Manufacturing Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OK Plus Indicator?

The FDA product code for OK Plus Indicator is JOJ.

列明Propper Manufacturing Co., 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。

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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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