FDA 510(k)

中藝NeutrArt

K 號：K201872 · 2021-01-05

決定日期2021-01-05

產品代碼FPA

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

NeutrArt is the device name listed in this FDA 510(k) record. The listed applicant is Asset Medikal Tasarim As.. It received FDA 510(k) clearance on 2021-01-05 under 510(k) number K201872. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NeutrArt?

NeutrArt is a medical device that received FDA 510(k) clearance on 2021-01-05. The listed applicant is Asset Medikal Tasarim As.. The 510(k) number is K201872.

When did NeutrArt receive FDA 510(k) clearance?

NeutrArt received FDA 510(k) clearance on 2021-01-05, under 510(k) number K201872.

Who is the listed applicant for NeutrArt?

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

What is the FDA product code for NeutrArt?

The FDA product code for NeutrArt is FPA.

其他以 Asset Medikal Tasarim As. 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。

K221473Flowart K221481中藝NeutrArt K190806Flowart

相關器械（代碼：FPA）

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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