FDA 510(k)

非接觸紅外線體溫計，型號 JXB-315、JXB-319、JXB-320、JXB-311

K 號：K213082 · 2022-01-28

申請人Guangzhou Berrcom Medical Device Co., Ltd.

決定日期2022-01-28

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

Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311 is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Berrcom Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2022-01-28 under 510(k) number K213082. 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 Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311?

Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311 is a medical device that received FDA 510(k) clearance on 2022-01-28. The listed applicant is Guangzhou Berrcom Medical Device Co., Ltd.. The 510(k) number is K213082.

When did Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311 receive FDA 510(k) clearance?

Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311 received FDA 510(k) clearance on 2022-01-28, under 510(k) number K213082.

Who is the listed applicant for Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311?

The FDA 510(k) record lists Guangzhou Berrcom Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311?

The FDA product code for Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311 is FLL.

其他以 Guangzhou Berrcom Medical Device 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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