FDA 510(k)

SIS系統

K 號：K241083 · 2024-06-14

決定日期2024-06-14

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

SIS System is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Information Sciences, Inc.. It received FDA 510(k) clearance on 2024-06-14 under 510(k) number K241083. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SIS System?

SIS System is a medical device that received FDA 510(k) clearance on 2024-06-14. The listed applicant is Surgical Information Sciences, Inc.. The 510(k) number is K241083.

When did SIS System receive FDA 510(k) clearance?

SIS System received FDA 510(k) clearance on 2024-06-14, under 510(k) number K241083.

Who is the listed applicant for SIS System?

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

What is the FDA product code for SIS System?

The FDA product code for SIS System is QIH.

其他以 Surgical Information Sciences, Inc. 為申請人之記錄

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相關器械（代碼：QIH）

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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