FDA 510(k)

時鐘智慧按鈕

K 號：K212217 · 2022-09-16

決定日期2022-09-16

產品代碼QOG

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

Tempo Smart Button is the device name listed in this FDA 510(k) record. The listed applicant is Eli Lilly and Company. It received FDA 510(k) clearance on 2022-09-16 under 510(k) number K212217. The device is classified under product code QOG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Tempo Smart Button?

Tempo Smart Button is a medical device that received FDA 510(k) clearance on 2022-09-16. The listed applicant is Eli Lilly and Company. The 510(k) number is K212217.

When did Tempo Smart Button receive FDA 510(k) clearance?

Tempo Smart Button received FDA 510(k) clearance on 2022-09-16, under 510(k) number K212217.

Who is the listed applicant for Tempo Smart Button?

The FDA 510(k) record lists Eli Lilly and Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tempo Smart Button?

The FDA product code for Tempo Smart Button is QOG.

其他以 Eli Lilly and Company 為申請人之記錄

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相關器械（代碼：QOG）

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官方來源

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