FDA 510(k)

埃佛里安+系統

K 號：K213863 · 2023-02-23

決定日期2023-02-23

產品代碼MSX

諮詢委員會履歷

決定相當於

器材摘要

Everion+ System is the device name listed in this FDA 510(k) record. The listed applicant is Biofourmis Singapore Pte., Ltd.. It received FDA 510(k) clearance on 2023-02-23 under 510(k) number K213863. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Everion+ System?

Everion+ System is a medical device that received FDA 510(k) clearance on 2023-02-23. The listed applicant is Biofourmis Singapore Pte., Ltd.. The 510(k) number is K213863.

When did Everion+ System receive FDA 510(k) clearance?

Everion+ System received FDA 510(k) clearance on 2023-02-23, under 510(k) number K213863.

Who is the listed applicant for Everion+ System?

The FDA 510(k) record lists Biofourmis Singapore Pte., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Everion+ System?

The FDA product code for Everion+ System is MSX.

其他以 Biofourmis Singapore Pte., Ltd. 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。

K233418Biofourmis Everion+ (G2)K183282生物生命數據分析引擎 K182344節律分析器

相關器械（代碼：MSX）

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。

K261287數位統計護理Ascom Ums Srl Unipersonale K260211儀表板（P007000）Hill-Rom, Inc.K261367柯薩諾 CardioWatch 287-2 系統Corsano Health B.V.K253654IntelliVue測量架6000（867317）Philips Medizin Systeme Böblingen GmbH K243270虎連接警報管理Tigerconnect K242728BeneVision 中央監控系統Shenzhen Mindray Bio-Medical Electronics 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。