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FDA 510(k)

醫用紅外線體溫計（型號：RST-TC59-1001，RST-TC60-1001）

K 號：K220657 · 2023-02-10

申請人Zhejiang Rongsheng Industrial Co., Ltd.
決定日期2023-02-10
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

Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001) is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Rongsheng Industrial Co., Ltd.. It received FDA 510(k) clearance on 2023-02-10 under 510(k) number K220657. 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 Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001)?

Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001) is a medical device that received FDA 510(k) clearance on 2023-02-10. The listed applicant is Zhejiang Rongsheng Industrial Co., Ltd.. The 510(k) number is K220657.

When did Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001) receive FDA 510(k) clearance?

Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001) received FDA 510(k) clearance on 2023-02-10, under 510(k) number K220657.

Who is the listed applicant for Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001)?

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

What is the FDA product code for Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001)?

The FDA product code for Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001) 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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