FDA 510(k)

GlucoLeader 加強型血糖監測系統

K 號：K182428 · 2019-05-08

決定日期2019-05-08

產品代碼NBW

諮詢委員會CH

決定相當於

器材摘要

GlucoLeader Enhance Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Hmd Biomedical, Inc.. It received FDA 510(k) clearance on 2019-05-08 under 510(k) number K182428. 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 GlucoLeader Enhance Blood Glucose Monitoring System?

GlucoLeader Enhance Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2019-05-08. The listed applicant is Hmd Biomedical, Inc.. The 510(k) number is K182428.

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

GlucoLeader Enhance Blood Glucose Monitoring System received FDA 510(k) clearance on 2019-05-08, under 510(k) number K182428.

Who is the listed applicant for GlucoLeader Enhance Blood Glucose Monitoring System?

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

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

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

其他以 Hmd Biomedical, Inc. 為申請人之記錄

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K212248GlucoLeader Enhance 2 血糖監測系統

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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官方來源

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