FDA 510(k)

RIGHTEST 血糖モニタリングシステムマックステル

K番号: K231192 · 2024-01-19

決定日2024-01-19

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

RIGHTEST Blood Glucose Monitoring System Max Tel is the device name listed in this FDA 510(k) record. The listed applicant is Bionime Corporation. It received FDA 510(k) clearance on 2024-01-19 under 510(k) number K231192. 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 RIGHTEST Blood Glucose Monitoring System Max Tel?

RIGHTEST Blood Glucose Monitoring System Max Tel is a medical device that received FDA 510(k) clearance on 2024-01-19. The listed applicant is Bionime Corporation. The 510(k) number is K231192.

When did RIGHTEST Blood Glucose Monitoring System Max Tel receive FDA 510(k) clearance?

RIGHTEST Blood Glucose Monitoring System Max Tel received FDA 510(k) clearance on 2024-01-19, under 510(k) number K231192.

Who is the listed applicant for RIGHTEST Blood Glucose Monitoring System Max Tel?

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

What is the FDA product code for RIGHTEST Blood Glucose Monitoring System Max Tel?

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

申請者としてBionime Corporationを記載するその他の記録

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公式ソース

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データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。