FDA 510(k)

BGM014 血糖モニタリングシステム、BGM014 プロ血糖モニタリングシステム

K番号: K161299 · 2016-12-23

決定日2016-12-23

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

BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System is the device name listed in this FDA 510(k) record. The listed applicant is Apex BioTechnology Corp.. It received FDA 510(k) clearance on 2016-12-23 under 510(k) number K161299. 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 BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System?

BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System is a medical device that received FDA 510(k) clearance on 2016-12-23. The listed applicant is Apex BioTechnology Corp.. The 510(k) number is K161299.

When did BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System receive FDA 510(k) clearance?

BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System received FDA 510(k) clearance on 2016-12-23, under 510(k) number K161299.

Who is the listed applicant for BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System?

The FDA 510(k) record lists Apex BioTechnology Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System?

The FDA product code for BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System is NBW. This falls under the OB/GYN category.