FDA 510(k)

Avazzia

K 號：K162392 · 2017-05-12

決定日期2017-05-12

產品代碼NUH

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

Avazzia is the device name listed in this FDA 510(k) record. The listed applicant is Avazzia, Inc.. It received FDA 510(k) clearance on 2017-05-12 under 510(k) number K162392. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Avazzia?

Avazzia is a medical device that received FDA 510(k) clearance on 2017-05-12. The listed applicant is Avazzia, Inc.. The 510(k) number is K162392.

When did Avazzia receive FDA 510(k) clearance?

Avazzia received FDA 510(k) clearance on 2017-05-12, under 510(k) number K162392.

Who is the listed applicant for Avazzia?

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

What is the FDA product code for Avazzia?

The FDA product code for Avazzia is NUH.

其他以 Avazzia, Inc. 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。

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相關器械（代碼：NUH）

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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