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FDA 510(k)

UltraEzAir® (UEA1A)

K-Number: K240114 · 2024-10-16

Decision Date2024-10-16
Product CodeCCT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the UltraEzAir® (UEA1A)?

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

When was UltraEzAir® (UEA1A) approved by the FDA?

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

What company makes UltraEzAir® (UEA1A)?

UltraEzAir® (UEA1A) is manufactured by Dualams, Inc., Dba Airkor.

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

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

Related Devices (Code: CCT)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.