免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据,仅供一般参考,不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

红外体温计型号RN-50A,RN-50B

K号: K200578 · 2020-07-16

决定日期2020-07-16
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

Infrared Thermometer Model Number RN-50A,RN-50B is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Ranor Medical Science & Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-07-16 under 510(k) number K200578. 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 Infrared Thermometer Model Number RN-50A,RN-50B?

Infrared Thermometer Model Number RN-50A,RN-50B is a medical device that received FDA 510(k) clearance on 2020-07-16. The listed applicant is Ningbo Ranor Medical Science & Technology Co., Ltd.. The 510(k) number is K200578.

When did Infrared Thermometer Model Number RN-50A,RN-50B receive FDA 510(k) clearance?

Infrared Thermometer Model Number RN-50A,RN-50B received FDA 510(k) clearance on 2020-07-16, under 510(k) number K200578.

Who is the listed applicant for Infrared Thermometer Model Number RN-50A,RN-50B?

The FDA 510(k) record lists Ningbo Ranor Medical Science & Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infrared Thermometer Model Number RN-50A,RN-50B?

The FDA product code for Infrared Thermometer Model Number RN-50A,RN-50B is FLL.

相关临床试验

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。

列明Ningbo Ranor Medical Science & Technology 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。

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。

↑