FDA 510(k)

DR 100s

K 號：K191884 · 2019-08-09

決定日期2019-08-09

產品代碼IZL

諮詢委員會RA

決定相當於

器材摘要

DR 100s is the device name listed in this FDA 510(k) record. The listed applicant is Agfa N.V.. It received FDA 510(k) clearance on 2019-08-09 under 510(k) number K191884. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DR 100s?

DR 100s is a medical device that received FDA 510(k) clearance on 2019-08-09. The listed applicant is Agfa N.V.. The 510(k) number is K191884.

When did DR 100s receive FDA 510(k) clearance?

DR 100s received FDA 510(k) clearance on 2019-08-09, under 510(k) number K191884.

Who is the listed applicant for DR 100s?

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

What is the FDA product code for DR 100s?

The FDA product code for DR 100s is IZL.

其他以 Agfa N.V. 為申請人之記錄

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相關器械（代碼：IZL）

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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