FDA 510(k)

GlucoLeader Enhance 2 血糖监测系统

K号: K212248 · 2022-08-29

决定日期2022-08-29

产品代码NBW

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

GlucoLeader Enhance 2 Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Hmd Biomedical, Inc.. It received FDA 510(k) clearance on 2022-08-29 under 510(k) number K212248. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the GlucoLeader Enhance 2 Blood Glucose Monitoring System?

GlucoLeader Enhance 2 Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2022-08-29. The listed applicant is Hmd Biomedical, Inc.. The 510(k) number is K212248.

When did GlucoLeader Enhance 2 Blood Glucose Monitoring System receive FDA 510(k) clearance?

GlucoLeader Enhance 2 Blood Glucose Monitoring System received FDA 510(k) clearance on 2022-08-29, under 510(k) number K212248.

Who is the listed applicant for GlucoLeader Enhance 2 Blood Glucose Monitoring System?

The FDA 510(k) record lists Hmd Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GlucoLeader Enhance 2 Blood Glucose Monitoring System?

The FDA product code for GlucoLeader Enhance 2 Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

列明Hmd 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。

K182428GlucoLeader Enhance 血糖监测系统

相关器械（代码：NBW）

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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