AIO Breathe— 510(k) K233754

Substantially Equivalent

Aiomega, LLC

FDA 510(k) clearance K233754 for AIO Breathe, Substantially Equivalent on 2024-02-23. Applicant: Aiomega, LLC. Device class: 2.

Clearance details

Applicant: Aiomega, LLC
Product code: Code LQZ
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 2023-11-22
Decision date: 2024-02-23
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Tyler, TX, US

Download summary PDF View on FDA.gov ↗

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More clearances from Aiomega, LLC

K252525 — AIO Breathe2025-11-06

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