FDA 510(k)

Eversense 365 持続的血糖監視（CGM）システム

K番号: K241335 · 2024-09-16

決定日2024-09-16

製品コードSBA

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

Eversense 365 Continuous Glucose Monitoring (CGM) System is the device name listed in this FDA 510(k) record. The listed applicant is Senseonics, Incorporated. It received FDA 510(k) clearance on 2024-09-16 under 510(k) number K241335. The device is classified under product code SBA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Eversense 365 Continuous Glucose Monitoring (CGM) System?

Eversense 365 Continuous Glucose Monitoring (CGM) System is a medical device that received FDA 510(k) clearance on 2024-09-16. The listed applicant is Senseonics, Incorporated. The 510(k) number is K241335.

When did Eversense 365 Continuous Glucose Monitoring (CGM) System receive FDA 510(k) clearance?

Eversense 365 Continuous Glucose Monitoring (CGM) System received FDA 510(k) clearance on 2024-09-16, under 510(k) number K241335.

Who is the listed applicant for Eversense 365 Continuous Glucose Monitoring (CGM) System?

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

What is the FDA product code for Eversense 365 Continuous Glucose Monitoring (CGM) System?

The FDA product code for Eversense 365 Continuous Glucose Monitoring (CGM) System is SBA.

公式ソース

FDAデータベースで見る →

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。

医療機器の概要

よくある質問

関連する臨床試験

公式ソース