FDA 510(k)

非接触式红外体温计，型号 JXB-315，JXB-319，JXB-320，JXB-311

K号: K213082 · 2022-01-28

申请人Guangzhou Berrcom Medical Device Co., Ltd.

决定日期2022-01-28

产品代码FLL

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

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.

常见问题

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.

列明Guangzhou Berrcom Medical Device Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K214077数字温度计，型号：DT007，DT008 K213746数字体温计，型号DT101，DT102 K213084耳温计，型号ET005，ET008，ET009 K213079耳温计，型号ET001 K191570红外体温计型号MD-H30

相关器械（代码：FLL）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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官方来源

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