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FDA 510(k)

UltraEzAir® (UEA1A)

K-Number: K240114 · 2024-10-16

ApplicantDualams, Inc., Dba Airkor
Decision Date2024-10-16
Product CodeCCT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: CCT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K172956Medicant Mucosal AtomizerMedica Holdings, LLCK153470MADgic Laryngo-Tracheal Mucosal Atomization DeviceTeleflex Medical

Official Source

View on FDA Database →

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

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