UltraEzAir® (UEA1A)— 510(k) K240114

Name: FDA 510(k) clearance K240114
Creator: U.S. Food and Drug Administration
Published: 2024-10-16

Substantially Equivalent

Dualams, Inc., Dba Airkor

FDA 510(k) clearance K240114 for UltraEzAir® (UEA1A), Substantially Equivalent on 2024-10-16. Applicant: Dualams, Inc., Dba Airkor. Device class: 2.

Clearance details

Applicant: Dualams, Inc., Dba Airkor
Product code: Code CCT
Device class: Class 2
Regulation: 21 CFR 868.5170
Advisory panel: Anesthesiology
Date received: 2024-01-16
Decision date: 2024-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CCT

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K172956 — Medicant Mucosal Atomizer2018-04-06
K153470 — MADgic Laryngo-Tracheal Mucosal Atomization Device2016-08-19
K093584 — EZ-MISTER2011-03-04
K070596 — TOPICAL APPLICATOR2007-06-21
K002255 — LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE (MADGIC)2000-09-18

Adverse events under product code CCT

product code CCT

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.