FDA 510(k)

FONA XDC

K 號：K222274 · 2022-08-23

決定日期2022-08-23

產品代碼EHD

諮詢委員會DE

決定相當於

器材摘要

FONA XDC is the device name listed in this FDA 510(k) record. The listed applicant is Fona S.R.L. It received FDA 510(k) clearance on 2022-08-23 under 510(k) number K222274. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the FONA XDC?

FONA XDC is a medical device that received FDA 510(k) clearance on 2022-08-23. The listed applicant is Fona S.R.L. The 510(k) number is K222274.

When did FONA XDC receive FDA 510(k) clearance?

FONA XDC received FDA 510(k) clearance on 2022-08-23, under 510(k) number K222274.

Who is the listed applicant for FONA XDC?

The FDA 510(k) record lists Fona S.R.L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FONA XDC?

The FDA product code for FONA XDC is EHD.

其他以 Fona S.R.L 為申請人之記錄

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。

K213579Stellaris 2D、Stellaris 2D 脱鹼、Stellaris 3D 及 Stellaris 3D 脱鹼 K212103星X-1、星X-2、星X PRO-1 及星X PRO-2 K161131FONA Pan/Ceph

相關器械（代碼：EHD）

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。

K260795手持式牙科X光系統（HyperLight-M）Changzhou Sifary Medical Technology Co., Ltd.K260367可攜式牙科X光系統型號 PDX novaPDX Co., Ltd.K253864NOMAD Pro 3Dental Imaging Technologies Corporation K252110牙科X光單元（AJX200）Guangzhou Ajax Medical Equipment Co., Ltd.K254018攜帶式牙科X光設備（GT-1）Guilin Refine Medical Instrument Co., Ltd.K252909診斷X光設備型號 POCT22Ningbo Runyes Medical Instrument Co., Ltd.

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。