AT-6XX系列红外温度计
K号: K171455 · 2018-02-09
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决定日期2018-02-09
产品代码FLL
咨询委员会医疗设备监管文本翻译如下：
HO
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决定实质等同
器械摘要
AT-6XX Series Infrared Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Xiamen Acurio Instruments Co., Ltd.. It received FDA 510(k) clearance on 2018-02-09 under 510(k) number K171455. 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 AT-6XX Series Infrared Thermometer?
AT-6XX Series Infrared Thermometer is a medical device that received FDA 510(k) clearance on 2018-02-09. The listed applicant is Xiamen Acurio Instruments Co., Ltd.. The 510(k) number is K171455.
When did AT-6XX Series Infrared Thermometer receive FDA 510(k) clearance?
AT-6XX Series Infrared Thermometer received FDA 510(k) clearance on 2018-02-09, under 510(k) number K171455.
Who is the listed applicant for AT-6XX Series Infrared Thermometer?
The FDA 510(k) record lists Xiamen Acurio Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AT-6XX Series Infrared Thermometer?
The FDA product code for AT-6XX Series Infrared Thermometer is FLL.
相关临床试验
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列明Xiamen Acurio Instruments 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。
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
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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