FDA 510(k)

Accu-Chek Guide Solo 糖尿病管理血糖监测系统

K号: K213131 · 2023-08-10

决定日期2023-08-10

产品代码NBW

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决定实质等同

器械摘要

Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diabetes Care GmbH. It received FDA 510(k) clearance on 2023-08-10 under 510(k) number K213131. 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 Accu-Chek Guide Solo diabetes manager blood glucose monitoring system?

Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is a medical device that received FDA 510(k) clearance on 2023-08-10. The listed applicant is Roche Diabetes Care GmbH. The 510(k) number is K213131.

When did Accu-Chek Guide Solo diabetes manager blood glucose monitoring system receive FDA 510(k) clearance?

Accu-Chek Guide Solo diabetes manager blood glucose monitoring system received FDA 510(k) clearance on 2023-08-10, under 510(k) number K213131.

Who is the listed applicant for Accu-Chek Guide Solo diabetes manager blood glucose monitoring system?

The FDA 510(k) record lists Roche Diabetes Care GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Accu-Chek Guide Solo diabetes manager blood glucose monitoring system?

The FDA product code for Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is NBW. This falls under the OB/GYN category.

列明Roche Diabetes Care GmbH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。

K213134Accu-Chek Solo 兼容技术微泵系统

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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