FDA 510(k)

OK Plus 指標

K 號：K222137 · 2022-12-05

決定日期2022-12-05

產品代碼JOJ

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

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.

常見問題

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.

其他以 Propper Manufacturing Co., Inc. 為申請人之記錄

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官方來源

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