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)

AEON-C™ 独立系統

K 號：K223140 · 2022-12-20

申請人Dio Medical, Inc.
決定日期2022-12-20
產品代碼OVE
諮詢委員會或
決定相當於

器材摘要

AEON-C™ Stand Alone System is the device name listed in this FDA 510(k) record. The listed applicant is Dio Medical, Inc.. It received FDA 510(k) clearance on 2022-12-20 under 510(k) number K223140. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AEON-C™ Stand Alone System?

AEON-C™ Stand Alone System is a medical device that received FDA 510(k) clearance on 2022-12-20. The listed applicant is Dio Medical, Inc.. The 510(k) number is K223140.

When did AEON-C™ Stand Alone System receive FDA 510(k) clearance?

AEON-C™ Stand Alone System received FDA 510(k) clearance on 2022-12-20, under 510(k) number K223140.

Who is the listed applicant for AEON-C™ Stand Alone System?

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

What is the FDA product code for AEON-C™ Stand Alone System?

The FDA product code for AEON-C™ Stand Alone System is OVE.

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：OVE）

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。

K263049SABER-C 系統Elevation SpineK261882Pisces-SC 独立颈椎間盤系統Osseus Fusions Systems, LLCK261451ZSAlign脊椎間盤系統ZSFab, Inc.K262094E3D™-C 間體系統Evolution SpineK261279DeltaNEC 間隙系統Nexus SpineK252982CONDUIT™ 零-P™ 維護隔離系統Avalign Technologies, Inc.

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。

↑