FDA 510(k)

CoLumboX

K 號：K250367 · 2025-05-28

決定日期2025-05-28

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

CoLumboX is the device name listed in this FDA 510(k) record. The listed applicant is Smart Soft Healthcare AD. It received FDA 510(k) clearance on 2025-05-28 under 510(k) number K250367. 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 CoLumboX?

CoLumboX is a medical device that received FDA 510(k) clearance on 2025-05-28. The listed applicant is Smart Soft Healthcare AD. The 510(k) number is K250367.

When did CoLumboX receive FDA 510(k) clearance?

CoLumboX received FDA 510(k) clearance on 2025-05-28, under 510(k) number K250367.

Who is the listed applicant for CoLumboX?

The FDA 510(k) record lists Smart Soft Healthcare AD as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CoLumboX?

The FDA product code for CoLumboX is QIH.

其他以 Smart Soft Healthcare AD 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。

K254015CoLumbo C脊椎 K220497CoLumbo

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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官方來源

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