FDA 510(k)

RII多功能紅外線體溫計，型號TH52Z

K 號：K162083 · 2017-01-09

決定日期2017-01-09

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

RII Multi-function Infrared Thermometer, Model TH52Z is the device name listed in this FDA 510(k) record. The listed applicant is Radiant Innovation, Inc.. It received FDA 510(k) clearance on 2017-01-09 under 510(k) number K162083. 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 RII Multi-function Infrared Thermometer, Model TH52Z?

RII Multi-function Infrared Thermometer, Model TH52Z is a medical device that received FDA 510(k) clearance on 2017-01-09. The listed applicant is Radiant Innovation, Inc.. The 510(k) number is K162083.

When did RII Multi-function Infrared Thermometer, Model TH52Z receive FDA 510(k) clearance?

RII Multi-function Infrared Thermometer, Model TH52Z received FDA 510(k) clearance on 2017-01-09, under 510(k) number K162083.

Who is the listed applicant for RII Multi-function Infrared Thermometer, Model TH52Z?

The FDA 510(k) record lists Radiant Innovation, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RII Multi-function Infrared Thermometer, Model TH52Z?

The FDA product code for RII Multi-function Infrared Thermometer, Model TH52Z is FLL.

其他以 Radiant Innovation, Inc. 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。

K240648非觸碰額頭式體溫計 (TH48FE, TH09F, THD2FE)K163601RII 智能遠紅外體溫計

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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