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FDA 510(k)

ARC InstaTemp 非觸碰式體溫計，ARC InstaTemp MD 非觸碰式體溫計

K 號：K152905 · 2016-07-20

申請人Arc Devices Limited
決定日期2016-07-20
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

ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Arc Devices Limited. It received FDA 510(k) clearance on 2016-07-20 under 510(k) number K152905. 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 ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer?

ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer is a medical device that received FDA 510(k) clearance on 2016-07-20. The listed applicant is Arc Devices Limited. The 510(k) number is K152905.

When did ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer receive FDA 510(k) clearance?

ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer received FDA 510(k) clearance on 2016-07-20, under 510(k) number K152905.

Who is the listed applicant for ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer?

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

What is the FDA product code for ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer?

The FDA product code for ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer is FLL.

相關臨床試驗

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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