FDA 510(k)

Bioland G-425-2V血糖监测系统，Bioland G-425-2血糖监测系统

K号: K202739 · 2022-08-12

决定日期2022-08-12

产品代码NBW

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决定实质等同

器械摘要

Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Bioland Technology, Ltd.. It received FDA 510(k) clearance on 2022-08-12 under 510(k) number K202739. 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 Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System?

Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2022-08-12. The listed applicant is Bioland Technology, Ltd.. The 510(k) number is K202739.

When did Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System receive FDA 510(k) clearance?

Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System received FDA 510(k) clearance on 2022-08-12, under 510(k) number K202739.

Who is the listed applicant for Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System?

The FDA 510(k) record lists Bioland Technology, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System?

The FDA product code for Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.