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FDA 510(k)

XVWeb 3D

K 號:K182815 · 2018-11-30

申請人Apteryx, Inc.
決定日期2018-11-30
產品代碼LLZ
諮詢委員會RA
決定相當於

器材摘要

XVWeb 3D is the device name listed in this FDA 510(k) record. The listed applicant is Apteryx, Inc.. It received FDA 510(k) clearance on 2018-11-30 under 510(k) number K182815. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the XVWeb 3D?

XVWeb 3D is a medical device that received FDA 510(k) clearance on 2018-11-30. The listed applicant is Apteryx, Inc.. The 510(k) number is K182815.

When did XVWeb 3D receive FDA 510(k) clearance?

XVWeb 3D received FDA 510(k) clearance on 2018-11-30, under 510(k) number K182815.

Who is the listed applicant for XVWeb 3D?

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

What is the FDA product code for XVWeb 3D?

The FDA product code for XVWeb 3D is LLZ.

相關臨床試驗

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相關器械(代碼:LLZ)

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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