RADx Intraoral Appliance for Snoring and Sleep Apnea— 510(k) K230532

Name: FDA 510(k) clearance K230532
Creator: U.S. Food and Drug Administration
Published: 2023-07-12

Substantially Equivalent

Achaemenid, LLC

FDA 510(k) clearance K230532 for RADx Intraoral Appliance for Snoring and Sleep Apnea, Substantially Equivalent on 2023-07-12. Applicant: Achaemenid, LLC. Device class: 2.

Clearance details

Applicant: Achaemenid, LLC
Product code: Code LQZ
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 2023-02-27
Decision date: 2023-07-12
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Stratford, CT, US

Download summary PDF View on FDA.gov ↗

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