FDA 510(k)

AW-100

K 號：K171150 · 2018-03-08

決定日期2018-03-08

產品代碼ELC

諮詢委員會DE

決定相當於

器材摘要

AW-100 is the device name listed in this FDA 510(k) record. The listed applicant is Micron Corporation. It received FDA 510(k) clearance on 2018-03-08 under 510(k) number K171150. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AW-100?

AW-100 is a medical device that received FDA 510(k) clearance on 2018-03-08. The listed applicant is Micron Corporation. The 510(k) number is K171150.

When did AW-100 receive FDA 510(k) clearance?

AW-100 received FDA 510(k) clearance on 2018-03-08, under 510(k) number K171150.

Who is the listed applicant for AW-100?

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

What is the FDA product code for AW-100?

The FDA product code for AW-100 is ELC.

其他以 Micron Corporation 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。

K161639Y-MIC

相關器械（代碼：ELC）

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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