FDA 510(k)

VivaChek 血糖和β-酮体监测系统

K号: K192957 · 2020-06-05

申请人Vivachek Biotech (Hangzhou) Co., Ltd.

决定日期2020-06-05

产品代码JIN

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

VivaChek Blood Glucose and B-Ketone Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Vivachek Biotech (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2020-06-05 under 510(k) number K192957. The device is classified under product code JIN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VivaChek Blood Glucose and B-Ketone Monitoring System?

VivaChek Blood Glucose and B-Ketone Monitoring System is a medical device that received FDA 510(k) clearance on 2020-06-05. The listed applicant is Vivachek Biotech (Hangzhou) Co., Ltd.. The 510(k) number is K192957.

When did VivaChek Blood Glucose and B-Ketone Monitoring System receive FDA 510(k) clearance?

VivaChek Blood Glucose and B-Ketone Monitoring System received FDA 510(k) clearance on 2020-06-05, under 510(k) number K192957.

Who is the listed applicant for VivaChek Blood Glucose and B-Ketone Monitoring System?

The FDA 510(k) record lists Vivachek Biotech (Hangzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VivaChek Blood Glucose and B-Ketone Monitoring System?

The FDA product code for VivaChek Blood Glucose and B-Ketone Monitoring System is JIN.

列明Vivachek Biotech (Hangzhou) 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。

K261280BioSieve多药物尿液测试板；BioSieve多药物尿液家庭测试板 K252554Wisdiag 多药物尿液检测杯；Wisdiag 多药物尿液家庭检测杯 K241869BioSieve™芬太尼FIA家庭测试套件；BioSieve™芬太尼FIA专业测试套件；BioSieve™ Toxismart阅读器 K222126VivaChek™ Fad 血糖监测系统，VivaChek™ Fad 智能血糖监测系统，VivaChek™ Fad 同步血糖监测系统 K240124BioSieve™芬太尼FIA测试套件；BioSieve™ ToxiSmart FIA阅读器 K233058VivaChek Link Plus 血糖监测系统

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