FDA 510(k)

UltraEzAir® (UEA1A)

K 號：K240114 · 2024-10-16

決定日期2024-10-16

產品代碼CCT

諮詢委員會AN

決定相當於

器材摘要

UltraEzAir® (UEA1A) is the device name listed in this FDA 510(k) record. The listed applicant is Dualams, Inc., Dba Airkor. It received FDA 510(k) clearance on 2024-10-16 under 510(k) number K240114. The device is classified under product code CCT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the UltraEzAir® (UEA1A)?

UltraEzAir® (UEA1A) is a medical device that received FDA 510(k) clearance on 2024-10-16. The listed applicant is Dualams, Inc., Dba Airkor. The 510(k) number is K240114.

When did UltraEzAir® (UEA1A) receive FDA 510(k) clearance?

UltraEzAir® (UEA1A) received FDA 510(k) clearance on 2024-10-16, under 510(k) number K240114.

Who is the listed applicant for UltraEzAir® (UEA1A)?

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

What is the FDA product code for UltraEzAir® (UEA1A)?

The FDA product code for UltraEzAir® (UEA1A) is CCT.

相關器械（代碼：CCT）

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器材摘要

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相關臨床試驗

相關器械（代碼：CCT）

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