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FDA 510(k)

黏膜阻抗測量系統

K 號:K233974 · 2024-09-06

決定日期2024-09-06
產品代碼QIS
諮詢委員會GU
決定相當於

器材摘要

Mucosal Impedance Measurement System is the device name listed in this FDA 510(k) record. The listed applicant is Alandra Medical Sapi DE CV. It received FDA 510(k) clearance on 2024-09-06 under 510(k) number K233974. The device is classified under product code QIS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Mucosal Impedance Measurement System?

Mucosal Impedance Measurement System is a medical device that received FDA 510(k) clearance on 2024-09-06. The listed applicant is Alandra Medical Sapi DE CV. The 510(k) number is K233974.

When did Mucosal Impedance Measurement System receive FDA 510(k) clearance?

Mucosal Impedance Measurement System received FDA 510(k) clearance on 2024-09-06, under 510(k) number K233974.

Who is the listed applicant for Mucosal Impedance Measurement System?

The FDA 510(k) record lists Alandra Medical Sapi DE CV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mucosal Impedance Measurement System?

The FDA product code for Mucosal Impedance Measurement System is QIS.

相關臨床試驗

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相關器械(代碼:QIS)

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。

官方來源

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