FDA 510(k)

Veuron-Brain-mN1

K 號：K203279 · 2022-07-12

決定日期2022-07-12

產品代碼LNH

諮詢委員會RA

決定相當於

器材摘要

Veuron-Brain-mN1 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 2022-07-12 under 510(k) number K203279. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Veuron-Brain-mN1?

Veuron-Brain-mN1 is a medical device that received FDA 510(k) clearance on 2022-07-12. The listed applicant is Heuron Co., Ltd.. The 510(k) number is K203279.

When did Veuron-Brain-mN1 receive FDA 510(k) clearance?

Veuron-Brain-mN1 received FDA 510(k) clearance on 2022-07-12, under 510(k) number K203279.

Who is the listed applicant for Veuron-Brain-mN1?

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-mN1?

The FDA product code for Veuron-Brain-mN1 is LNH.

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 K231642Veuron-Brain-pAb3 K213801Veuron-Brain-pAb2 K203142Veuron-Brain-pAb

相關器械（代碼：LNH）

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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官方來源

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