FDA 510(k)

中心醫療病人對應輔助手術計劃（ASP）系統

K 號：K201353 · 2021-06-28

決定日期2021-06-28

產品代碼DZJ

諮詢委員會DE

決定相當於

器材摘要

CenterMed Patient Matched Assisted Surgical Planning (ASP) System is the device name listed in this FDA 510(k) record. The listed applicant is Centermed, Inc.. It received FDA 510(k) clearance on 2021-06-28 under 510(k) number K201353. The device is classified under product code DZJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CenterMed Patient Matched Assisted Surgical Planning (ASP) System?

CenterMed Patient Matched Assisted Surgical Planning (ASP) System is a medical device that received FDA 510(k) clearance on 2021-06-28. The listed applicant is Centermed, Inc.. The 510(k) number is K201353.

When did CenterMed Patient Matched Assisted Surgical Planning (ASP) System receive FDA 510(k) clearance?

CenterMed Patient Matched Assisted Surgical Planning (ASP) System received FDA 510(k) clearance on 2021-06-28, under 510(k) number K201353.

Who is the listed applicant for CenterMed Patient Matched Assisted Surgical Planning (ASP) System?

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

What is the FDA product code for CenterMed Patient Matched Assisted Surgical Planning (ASP) System?

The FDA product code for CenterMed Patient Matched Assisted Surgical Planning (ASP) System is DZJ.

其他以 Centermed, Inc. 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。

K211614中心醫療病人對應輔助手術計劃（ASP）系統

相關器械（代碼：DZJ）

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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