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FDA 510(k)

Talis EMR 配合 Talis +ACG (Talis EMR 配合 +ACG)

K 號:K233133 · 2024-04-01

決定日期2024-04-01
產品代碼MWI
諮詢委員會履歷
決定相當於

器材摘要

Talis EMR with Talis +ACG (Talis EMR with +ACG) is the device name listed in this FDA 510(k) record. The listed applicant is Talis Clinical, LLC. It received FDA 510(k) clearance on 2024-04-01 under 510(k) number K233133. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Talis EMR with Talis +ACG (Talis EMR with +ACG)?

Talis EMR with Talis +ACG (Talis EMR with +ACG) is a medical device that received FDA 510(k) clearance on 2024-04-01. The listed applicant is Talis Clinical, LLC. The 510(k) number is K233133.

When did Talis EMR with Talis +ACG (Talis EMR with +ACG) receive FDA 510(k) clearance?

Talis EMR with Talis +ACG (Talis EMR with +ACG) received FDA 510(k) clearance on 2024-04-01, under 510(k) number K233133.

Who is the listed applicant for Talis EMR with Talis +ACG (Talis EMR with +ACG)?

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

What is the FDA product code for Talis EMR with Talis +ACG (Talis EMR with +ACG)?

The FDA product code for Talis EMR with Talis +ACG (Talis EMR with +ACG) is MWI.

相關臨床試驗

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。

相關器械(代碼:MWI)

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。

官方來源

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