FDA 510(k)

Accuvue+

K 號：K201058 · 2020-05-06

決定日期2020-05-06

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

Accuvue+ is the device name listed in this FDA 510(k) record. The listed applicant is Radmedix, LLC. It received FDA 510(k) clearance on 2020-05-06 under 510(k) number K201058. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Accuvue+?

Accuvue+ is a medical device that received FDA 510(k) clearance on 2020-05-06. The listed applicant is Radmedix, LLC. The 510(k) number is K201058.

When did Accuvue+ receive FDA 510(k) clearance?

Accuvue+ received FDA 510(k) clearance on 2020-05-06, under 510(k) number K201058.

Who is the listed applicant for Accuvue+?

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

What is the FDA product code for Accuvue+?

The FDA product code for Accuvue+ is MQB.

其他以 Radmedix, LLC 為申請人之記錄

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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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