FDA 510(k)

DeltaScan 貼片

K 號：K222671 · 2023-02-02

決定日期2023-02-02

產品代碼GXY

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

DeltaScan Patch is the device name listed in this FDA 510(k) record. The listed applicant is Prolira B.V.. It received FDA 510(k) clearance on 2023-02-02 under 510(k) number K222671. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DeltaScan Patch?

DeltaScan Patch is a medical device that received FDA 510(k) clearance on 2023-02-02. The listed applicant is Prolira B.V.. The 510(k) number is K222671.

When did DeltaScan Patch receive FDA 510(k) clearance?

DeltaScan Patch received FDA 510(k) clearance on 2023-02-02, under 510(k) number K222671.

Who is the listed applicant for DeltaScan Patch?

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

What is the FDA product code for DeltaScan Patch?

The FDA product code for DeltaScan Patch is GXY.

其他以 Prolira B.V. 為申請人之記錄

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K222680DeltaScan 監視器

相關器械（代碼：GXY）

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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