Bigfoot Unity 糖尿病管理系统
K号: K202145 · 2021-05-07
广告
决定日期2021-05-07
产品代码QLG
咨询委员会CH
请注意，您提供的文本“CH”不足以进行翻译。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
Bigfoot Unity Diabetes Management System is the device name listed in this FDA 510(k) record. The listed applicant is Bigfoot Biomedical, Inc.. It received FDA 510(k) clearance on 2021-05-07 under 510(k) number K202145. The device is classified under product code QLG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Bigfoot Unity Diabetes Management System?
Bigfoot Unity Diabetes Management System is a medical device that received FDA 510(k) clearance on 2021-05-07. The listed applicant is Bigfoot Biomedical, Inc.. The 510(k) number is K202145.
When did Bigfoot Unity Diabetes Management System receive FDA 510(k) clearance?
Bigfoot Unity Diabetes Management System received FDA 510(k) clearance on 2021-05-07, under 510(k) number K202145.
Who is the listed applicant for Bigfoot Unity Diabetes Management System?
The FDA 510(k) record lists Bigfoot Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Bigfoot Unity Diabetes Management System?
The FDA product code for Bigfoot Unity Diabetes Management System is QLG.
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Bigfoot Biomedical, Inc.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：QLG）
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。
K222280Bigfoot Unity® 糖尿病管理系统Bigfoot Biomedical, Inc.K223537FreeStyle Libre 2系统，FreeStyle Libre 3系统Abbott Diabetes Care, Inc.K213996FreeStyle Libre 3连续血糖监测系统Abbott Diabetes Care, Inc.K212132FreeStyle Libre 3连续血糖监测系统Abbott Diabetes Care, Inc.K210943FreeStyle Libre 2闪式血糖监测系统（含FreeStyle Libre 2应用程序）Abbott Diabetes Care, Inc.K211102FreeStyle Libre 2闪式血糖监测系统Abbott Diabetes Care, Inc.
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。
广告