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FDA 510(k)

K 清晰

K 號:K220726 · 2022-03-16

決定日期2022-03-16
產品代碼NXC
諮詢委員會DE
決定相當於

器材摘要

K Clear is the device name listed in this FDA 510(k) record. The listed applicant is Kline Europe GmbH. It received FDA 510(k) clearance on 2022-03-16 under 510(k) number K220726. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the K Clear?

K Clear is a medical device that received FDA 510(k) clearance on 2022-03-16. The listed applicant is Kline Europe GmbH. The 510(k) number is K220726.

When did K Clear receive FDA 510(k) clearance?

K Clear received FDA 510(k) clearance on 2022-03-16, under 510(k) number K220726.

Who is the listed applicant for K Clear?

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

What is the FDA product code for K Clear?

The FDA product code for K Clear is NXC.

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相關器械(代碼:NXC)

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。

官方來源

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