FDA 510(k)

紅外線體溫計，型號：JKH-300、JKH-301、JKH-302、JKH-303、JKH-304

K 號：K211050 · 2022-11-28

決定日期2022-11-28

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, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304 is the device name listed in this FDA 510(k) record. The listed applicant is Jkh Health Co., Ltd.. It received FDA 510(k) clearance on 2022-11-28 under 510(k) number K211050. 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, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304?

Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304 is a medical device that received FDA 510(k) clearance on 2022-11-28. The listed applicant is Jkh Health Co., Ltd.. The 510(k) number is K211050.

When did Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304 receive FDA 510(k) clearance?

Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304 received FDA 510(k) clearance on 2022-11-28, under 510(k) number K211050.

Who is the listed applicant for Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304?

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

What is the FDA product code for Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304?

The FDA product code for Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304 is FLL.

其他以 Jkh Health Co., Ltd. 為申請人之記錄

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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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