FDA 510(k)

Rightest 血糖監測系統 GM700S，Rightest 血糖監測系統 GM700SB

K 號：K190564 · 2019-06-02

決定日期2019-06-02

產品代碼NBW

諮詢委員會CH

決定相當於

器材摘要

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.

常見問題

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.