免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料,僅供一般參考,不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

SugarBug (1.x)

K 號:K250264 · 2025-11-07

申請人Bench7, Inc.
決定日期2025-11-07
產品代碼MYN
諮詢委員會RA
決定相當於

器材摘要

SugarBug (1.x) is the device name listed in this FDA 510(k) record. The listed applicant is Bench7, Inc.. It received FDA 510(k) clearance on 2025-11-07 under 510(k) number K250264. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SugarBug (1.x)?

SugarBug (1.x) is a medical device that received FDA 510(k) clearance on 2025-11-07. The listed applicant is Bench7, Inc.. The 510(k) number is K250264.

When did SugarBug (1.x) receive FDA 510(k) clearance?

SugarBug (1.x) received FDA 510(k) clearance on 2025-11-07, under 510(k) number K250264.

Who is the listed applicant for SugarBug (1.x)?

The FDA 510(k) record lists Bench7, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SugarBug (1.x)?

The FDA product code for SugarBug (1.x) is MYN.

相關臨床試驗

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。

相關器械(代碼:MYN)

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。

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊,請始終參閱官方記錄。

↑