AViTA 雷达红外线体温计 NT16 系列红外线体温计
K号: K172427 · 2018-04-19
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决定日期2018-04-19
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
AViTA Radar Thermo NT16 Series IR Thermometer is the device name listed in this FDA 510(k) record. The listed applicant is Avita Corporation. It received FDA 510(k) clearance on 2018-04-19 under 510(k) number K172427. 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 AViTA Radar Thermo NT16 Series IR Thermometer?
AViTA Radar Thermo NT16 Series IR Thermometer is a medical device that received FDA 510(k) clearance on 2018-04-19. The listed applicant is Avita Corporation. The 510(k) number is K172427.
When did AViTA Radar Thermo NT16 Series IR Thermometer receive FDA 510(k) clearance?
AViTA Radar Thermo NT16 Series IR Thermometer received FDA 510(k) clearance on 2018-04-19, under 510(k) number K172427.
Who is the listed applicant for AViTA Radar Thermo NT16 Series IR Thermometer?
The FDA 510(k) record lists Avita Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AViTA Radar Thermo NT16 Series IR Thermometer?
The FDA product code for AViTA Radar Thermo NT16 Series IR Thermometer is FLL.
相关临床试验
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列明Avita Corporation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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