FDA 510(k)

GlucoLeader 高性能血糖监测システム

K番号: K182428 · 2019-05-08

決定日2019-05-08

製品コードNBW

諮問委員会CH 当社の医療機器は、FDA（米国食品医薬品局）の規制に従って製造・販売されています。製品は、510(k)通知書およびPMA（プレマーケティング評価）を通じて承認を受けています。臨床試験情報は、NCT（臨床試験登録番号）およびPMID（PubMed ID）で確認できます。詳細については、以下のURLをご参照ください。 [URL]

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてHmd Biomedical, Inc.を記載するその他の記録

K212248GlucoLeader Enhance 2 血糖監測システム

公式ソース

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