FDA 510(k)

3D自動LAA

K 號：K201352 · 2020-08-17

決定日期2020-08-17

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

3D Auto LAA is the device name listed in this FDA 510(k) record. The listed applicant is Philips Health Care. It received FDA 510(k) clearance on 2020-08-17 under 510(k) number K201352. 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 3D Auto LAA?

3D Auto LAA is a medical device that received FDA 510(k) clearance on 2020-08-17. The listed applicant is Philips Health Care. The 510(k) number is K201352.

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

3D Auto LAA received FDA 510(k) clearance on 2020-08-17, under 510(k) number K201352.

Who is the listed applicant for 3D Auto LAA?

The FDA 510(k) record lists Philips Health Care as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3D Auto LAA?

The FDA product code for 3D Auto LAA is LLZ.

其他以 Philips Health Care 為申請人之記錄

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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。

K261874Syneris PACS v.1.0.1.0Syneris K262442HipStudio分析Replasia BV K261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

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