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FDA 510(k)

分子流動模擬

K 號:K201435 · 2021-12-03

決定日期2021-12-03
產品代碼HAW
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

Molecular Flow Simulations is the device name listed in this FDA 510(k) record. The listed applicant is Therataxis, LLC. It received FDA 510(k) clearance on 2021-12-03 under 510(k) number K201435. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Molecular Flow Simulations?

Molecular Flow Simulations is a medical device that received FDA 510(k) clearance on 2021-12-03. The listed applicant is Therataxis, LLC. The 510(k) number is K201435.

When did Molecular Flow Simulations receive FDA 510(k) clearance?

Molecular Flow Simulations received FDA 510(k) clearance on 2021-12-03, under 510(k) number K201435.

Who is the listed applicant for Molecular Flow Simulations?

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

What is the FDA product code for Molecular Flow Simulations?

The FDA product code for Molecular Flow Simulations is HAW.

相關臨床試驗

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相關器械(代碼:HAW)

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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