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)

Deep Capsule® (Deep Capsule US)

K 號:K250655 · 2026-03-12

決定日期2026-03-12
產品代碼QZF
諮詢委員會GU
決定Substantially Equivalent

器材摘要

Deep Capsule® (Deep Capsule US) is the device name listed in this FDA 510(k) record. The listed applicant is Digestaid - Artificial Intelligence Development SA. It received FDA 510(k) clearance on 2026-03-12 under 510(k) number K250655. The device is classified under product code QZF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Deep Capsule® (Deep Capsule US)?

Deep Capsule® (Deep Capsule US) is a medical device that received FDA 510(k) clearance on 2026-03-12. The listed applicant is Digestaid - Artificial Intelligence Development SA. The 510(k) number is K250655.

When did Deep Capsule® (Deep Capsule US) receive FDA 510(k) clearance?

Deep Capsule® (Deep Capsule US) received FDA 510(k) clearance on 2026-03-12, under 510(k) number K250655.

Who is the listed applicant for Deep Capsule® (Deep Capsule US)?

The FDA 510(k) record lists Digestaid - Artificial Intelligence Development SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Deep Capsule® (Deep Capsule US)?

The FDA product code for Deep Capsule® (Deep Capsule US) is QZF.

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:QZF)

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。

↑