FDA 510(k)

紅外線額頭溫度計，型號JZK-601、JZK-602、JZK-603

K 號：K203707 · 2021-03-12

申請人Shenzhen Zhengkang Technology Co., Ltd.

決定日期2021-03-12

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 Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Zhengkang Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-03-12 under 510(k) number K203707. 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 Forehead Thermometer, Model JZK-601, JZK-602, JZK-603?

Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 is a medical device that received FDA 510(k) clearance on 2021-03-12. The listed applicant is Shenzhen Zhengkang Technology Co., Ltd.. The 510(k) number is K203707.

When did Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 receive FDA 510(k) clearance?

Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 received FDA 510(k) clearance on 2021-03-12, under 510(k) number K203707.

Who is the listed applicant for Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603?

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

What is the FDA product code for Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603?

The FDA product code for Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 is FLL.

其他以 Shenzhen Zhengkang Technology 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。

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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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