FDA 510(k)

紅外耳溫濕度計型號：ET-100A、ET-100B、ET-100D、ET-100E、ET-100G、ET-100I、ET-100J

K 號：K172870 · 2018-02-13

申請人Hangzhou Hua'An Medical&Health Instruments Co.,Ltd

決定日期2018-02-13

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

Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Hua'An Medical&Health Instruments Co.,Ltd. It received FDA 510(k) clearance on 2018-02-13 under 510(k) number K172870. 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 Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J?

Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J is a medical device that received FDA 510(k) clearance on 2018-02-13. The listed applicant is Hangzhou Hua'An Medical&Health Instruments Co.,Ltd. The 510(k) number is K172870.

When did Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J receive FDA 510(k) clearance?

Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J received FDA 510(k) clearance on 2018-02-13, under 510(k) number K172870.

Who is the listed applicant for Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J?

The FDA 510(k) record lists Hangzhou Hua'An Medical&Health Instruments Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J?

The FDA product code for Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J is FLL.

其他以 Hangzhou Hua'An Medical&Health Instruments 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。

K172861數位體溫計（附可棄式體溫計蓋）K160999紅外線額頭溫度計

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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