FDA 510(k)

VS3立體高解析度視覺系統

K 號：K153548 · 2016-02-22

決定日期2016-02-22

產品代碼HRX

諮詢委員會或

決定相當於

器材摘要

VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Visionsense, Ltd.. It received FDA 510(k) clearance on 2016-02-22 under 510(k) number K153548. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM?

VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM is a medical device that received FDA 510(k) clearance on 2016-02-22. The listed applicant is Visionsense, Ltd.. The 510(k) number is K153548.

When did VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM receive FDA 510(k) clearance?

VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM received FDA 510(k) clearance on 2016-02-22, under 510(k) number K153548.

Who is the listed applicant for VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM?

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

What is the FDA product code for VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM?

The FDA product code for VS3 STEREOSCOPIC HIGH DEFINITION VISION SYSTEM is HRX.

其他以 Visionsense, 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。

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相關器械（代碼：HRX）

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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