FDA 510(k)

HJY視覺Next 3D內視鏡視覺系統

K 號：K243429 · 2025-05-21

決定日期2025-05-21

產品代碼GWG

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

HJY VisualNext 3D Endoscopic Vision System is the device name listed in this FDA 510(k) record. The listed applicant is Hjy Smart Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2025-05-21 under 510(k) number K243429. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HJY VisualNext 3D Endoscopic Vision System?

HJY VisualNext 3D Endoscopic Vision System is a medical device that received FDA 510(k) clearance on 2025-05-21. The listed applicant is Hjy Smart Medical Device Co., Ltd.. The 510(k) number is K243429.

When did HJY VisualNext 3D Endoscopic Vision System receive FDA 510(k) clearance?

HJY VisualNext 3D Endoscopic Vision System received FDA 510(k) clearance on 2025-05-21, under 510(k) number K243429.

Who is the listed applicant for HJY VisualNext 3D Endoscopic Vision System?

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

What is the FDA product code for HJY VisualNext 3D Endoscopic Vision System?

The FDA product code for HJY VisualNext 3D Endoscopic Vision System is GWG.

其他以 Hjy Smart Medical Device Co., Ltd. 為申請人之記錄

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K222735HJY視覺Next內視鏡視覺系統

相關器械（代碼：GWG）

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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