FDA 510(k)

數位體溫計

K 號：K172121 · 2018-06-07

決定日期2018-06-07

產品代碼FLL

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

Digital Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Fudakang Industrial Co., Ltd.. It received FDA 510(k) clearance on 2018-06-07 under 510(k) number K172121. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Digital Thermometer?

Digital Thermometer is a medical device that received FDA 510(k) clearance on 2018-06-07. The listed applicant is Fudakang Industrial Co., Ltd.. The 510(k) number is K172121.

When did Digital Thermometer receive FDA 510(k) clearance?

Digital Thermometer received FDA 510(k) clearance on 2018-06-07, under 510(k) number K172121.

Who is the listed applicant for Digital Thermometer?

The FDA 510(k) record lists Fudakang Industrial Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Digital Thermometer?

The FDA product code for Digital Thermometer is FLL.

其他以 Fudakang Industrial Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K160308富達康藍牙數位耳溫計（型號：BT-A41CN-BT）

相關器械（代碼：FLL）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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