FDA 510(k)

OEC 3D

K 號：K233669 · 2024-03-28

決定日期2024-03-28

產品代碼OXO

諮詢委員會RA

決定相當於

器材摘要

OEC 3D is the device name listed in this FDA 510(k) record. The listed applicant is Ge Oec Medical Systems, Inc.. It received FDA 510(k) clearance on 2024-03-28 under 510(k) number K233669. The device is classified under product code OXO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OEC 3D?

OEC 3D is a medical device that received FDA 510(k) clearance on 2024-03-28. The listed applicant is Ge Oec Medical Systems, Inc.. The 510(k) number is K233669.

When did OEC 3D receive FDA 510(k) clearance?

OEC 3D received FDA 510(k) clearance on 2024-03-28, under 510(k) number K233669.

Who is the listed applicant for OEC 3D?

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

What is the FDA product code for OEC 3D?

The FDA product code for OEC 3D is OXO.

其他以 Ge Oec Medical Systems, Inc. 為申請人之記錄

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K203346OEC 3D K192819OEC Elite K172550OEC Elite K171565OEC Elite

相關器械（代碼：OXO）

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。

K253296數位C-ARM搭配3DAllengers Medical Systems Limited K252579Orthoscan TAU MVP Mini C-Arm 系統Ziehm-Orthoscan, Inc.K253269OEC One 液體流體動力學設備Ge Hualun Medical Systems Co. , Ltd.K251004雙模式移動C臂（Geelin500A，Geelin500M）Hefei Chimed Intelligent Machine Co., Ltd.K250587Orthoscan TAU Mini C-臂Ziehm-Orthoscan, Inc.K243452Orthoscan VERSA Mini C-臂Ziehm-Orthoscan, Inc.

官方來源

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