FDA 510(k)

視覺監控器 - MonpackONE

K 號：K211643 · 2021-07-26

決定日期2021-07-26

產品代碼GWE

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Vision Monitor - MonpackONE is the device name listed in this FDA 510(k) record. The listed applicant is Metrovision. It received FDA 510(k) clearance on 2021-07-26 under 510(k) number K211643. The device is classified under product code GWE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Vision Monitor - MonpackONE?

Vision Monitor - MonpackONE is a medical device that received FDA 510(k) clearance on 2021-07-26. The listed applicant is Metrovision. The 510(k) number is K211643.

When did Vision Monitor - MonpackONE receive FDA 510(k) clearance?

Vision Monitor - MonpackONE received FDA 510(k) clearance on 2021-07-26, under 510(k) number K211643.

Who is the listed applicant for Vision Monitor - MonpackONE?

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

What is the FDA product code for Vision Monitor - MonpackONE?

The FDA product code for Vision Monitor - MonpackONE is GWE.

其他以 Metrovision 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。

K212936視覺監控器- MonCvONE

相關器械（代碼：GWE）

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。

K221471E3及配置檔Diagnosys, LLC K212936視覺監控器- MonCvONEMetrovision K211974LED光學系統Micromed S.P.A.K200705Nurochek系統Cryptych Pty, Ltd.K173936Natus光刺激器Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

官方來源

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