FDA 510(k)

Rightest 血糖监测系统 GM700S，Rightest 血糖监测系统 GM700SB

K号: K190564 · 2019-06-02

决定日期2019-06-02

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

Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB is the device name listed in this FDA 510(k) record. The listed applicant is Bionime Corporation. It received FDA 510(k) clearance on 2019-06-02 under 510(k) number K190564. 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 Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB?

Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB is a medical device that received FDA 510(k) clearance on 2019-06-02. The listed applicant is Bionime Corporation. The 510(k) number is K190564.

When did Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB receive FDA 510(k) clearance?

Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB received FDA 510(k) clearance on 2019-06-02, under 510(k) number K190564.

Who is the listed applicant for Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB?

The FDA 510(k) record lists Bionime Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB?

The FDA product code for Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB is NBW. This falls under the OB/GYN category.