FDA 510(k)

Veuron-Brain-pAb3

K 號：K231642 · 2023-10-13

決定日期2023-10-13

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Veuron-Brain-pAb3 is the device name listed in this FDA 510(k) record. The listed applicant is Heuron Co., Ltd.. It received FDA 510(k) clearance on 2023-10-13 under 510(k) number K231642. 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 Veuron-Brain-pAb3?

Veuron-Brain-pAb3 is a medical device that received FDA 510(k) clearance on 2023-10-13. The listed applicant is Heuron Co., Ltd.. The 510(k) number is K231642.

When did Veuron-Brain-pAb3 receive FDA 510(k) clearance?

Veuron-Brain-pAb3 received FDA 510(k) clearance on 2023-10-13, under 510(k) number K231642.

Who is the listed applicant for Veuron-Brain-pAb3?

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

What is the FDA product code for Veuron-Brain-pAb3?

The FDA product code for Veuron-Brain-pAb3 is LLZ.

其他以 Heuron Co., Ltd. 為申請人之記錄

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。

K233247Heuron ICH K203279Veuron-Brain-mN1 K213801Veuron-Brain-pAb2 K203142Veuron-Brain-pAb

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

官方來源

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