FDA 510(k)

數位統計智能中心

K 號：K180430 · 2018-11-23

決定日期2018-11-23

產品代碼MSX

諮詢委員會履歷

決定相當於

器材摘要

Digistat Smart Central is the device name listed in this FDA 510(k) record. The listed applicant is Ascom Ums Srl Unipersonale. It received FDA 510(k) clearance on 2018-11-23 under 510(k) number K180430. 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 Digistat Smart Central?

Digistat Smart Central is a medical device that received FDA 510(k) clearance on 2018-11-23. The listed applicant is Ascom Ums Srl Unipersonale. The 510(k) number is K180430.

When did Digistat Smart Central receive FDA 510(k) clearance?

Digistat Smart Central received FDA 510(k) clearance on 2018-11-23, under 510(k) number K180430.

Who is the listed applicant for Digistat Smart Central?

FDA 510(k) 記錄將 Ascom Ums Srl Unipersonale 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Digistat Smart Central?

The FDA product code for Digistat Smart Central is MSX.

其他以 Ascom Ums Srl Unipersonale 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。

K261287數位統計護理

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。

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官方來源

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