FDA 510(k)

IWL2020 血糖監測系統

K 號：K203711 · 2022-05-06

決定日期2022-05-06

產品代碼NBW

諮詢委員會CH

決定相當於

器材摘要

IWL2020 Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diabetes Care, Inc.. It received FDA 510(k) clearance on 2022-05-06 under 510(k) number K203711. 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 IWL2020 Blood Glucose Monitoring System?

IWL2020 Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2022-05-06. The listed applicant is Roche Diabetes Care, Inc.. The 510(k) number is K203711.

When did IWL2020 Blood Glucose Monitoring System receive FDA 510(k) clearance?

IWL2020 Blood Glucose Monitoring System received FDA 510(k) clearance on 2022-05-06, under 510(k) number K203711.

Who is the listed applicant for IWL2020 Blood Glucose Monitoring System?

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

What is the FDA product code for IWL2020 Blood Glucose Monitoring System?

The FDA product code for IWL2020 Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.

其他以 Roche Diabetes Care, Inc. 為申請人之記錄

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相關器械（代碼：NBW）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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