FDA 510(k)

Ultravision2™ 系統

K 號：K231238 · 2023-10-31

決定日期2023-10-31

產品代碼PQM

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Ultravision2™ System is the device name listed in this FDA 510(k) record. The listed applicant is Alesi Surgical, Ltd.. It received FDA 510(k) clearance on 2023-10-31 under 510(k) number K231238. The device is classified under product code PQM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ultravision2™ System?

Ultravision2™ System is a medical device that received FDA 510(k) clearance on 2023-10-31. The listed applicant is Alesi Surgical, Ltd.. The 510(k) number is K231238.

When did Ultravision2™ System receive FDA 510(k) clearance?

Ultravision2™ System received FDA 510(k) clearance on 2023-10-31, under 510(k) number K231238.

Who is the listed applicant for Ultravision2™ System?

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

What is the FDA product code for Ultravision2™ System?

The FDA product code for Ultravision2™ System is PQM.

其他以 Alesi Surgical, 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。

K231298超視2™系統整合單極L型勾針（H/S）™K200035超視野視野清除系統 K182053超視覺™ 视野清除系統 K170178超視野視野清除系統

相關器械（代碼：PQM）

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。

K240868超視覺2™ 電子筆Alesi Surgical Limited K231298超視2™系統整合單極L型勾針（H/S）™Alesi Surgical, Ltd.K200035超視野視野清除系統Alesi Surgical, Ltd.K182053超視覺™ 视野清除系統Alesi Surgical, Ltd.K170178超視野視野清除系統Alesi Surgical, Ltd.

官方來源

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