FDA 510(k)

紅外線體溫計 TET-351

K 號：K220276 · 2023-02-17

決定日期2023-02-17

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

Infrared Thermometer TET-351 is the device name listed in this FDA 510(k) record. The listed applicant is Truly Instrument Limited. It received FDA 510(k) clearance on 2023-02-17 under 510(k) number K220276. 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 Infrared Thermometer TET-351?

Infrared Thermometer TET-351 is a medical device that received FDA 510(k) clearance on 2023-02-17. The listed applicant is Truly Instrument Limited. The 510(k) number is K220276.

When did Infrared Thermometer TET-351 receive FDA 510(k) clearance?

Infrared Thermometer TET-351 received FDA 510(k) clearance on 2023-02-17, under 510(k) number K220276.

Who is the listed applicant for Infrared Thermometer TET-351?

The FDA 510(k) record lists Truly Instrument Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infrared Thermometer TET-351?

The FDA product code for Infrared Thermometer TET-351 is FLL.

其他以 Truly Instrument Limited 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。

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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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