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FDA 510(k)

RADx Intraoral Appliance for Snoring and Sleep Apnea

K-Number: K230532 · 2023-07-12

ApplicantAchaemenid, LLC
Decision Date2023-07-12
Product CodeLQZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RADx Intraoral Appliance for Snoring and Sleep Apnea is a medical device manufactured by Achaemenid, LLC. It received FDA 510(k) clearance on 2023-07-12 under approval number K230532. The device is classified under product code LQZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADx Intraoral Appliance for Snoring and Sleep Apnea?

RADx Intraoral Appliance for Snoring and Sleep Apnea is a medical device that received FDA 510(k) clearance on 2023-07-12. It is manufactured by Achaemenid, LLC. The 510(k) number is K230532.

When was RADx Intraoral Appliance for Snoring and Sleep Apnea approved by the FDA?

RADx Intraoral Appliance for Snoring and Sleep Apnea received FDA 510(k) clearance on 2023-07-12, under approval number K230532.

What company makes RADx Intraoral Appliance for Snoring and Sleep Apnea?

RADx Intraoral Appliance for Snoring and Sleep Apnea is manufactured by Achaemenid, LLC.

What is the FDA product code for RADx Intraoral Appliance for Snoring and Sleep Apnea?

The FDA product code for RADx Intraoral Appliance for Snoring and Sleep Apnea is LQZ.

Related Clinical Trials

NCT07613944 Ultrasound Assessment of Tongue Characteristics in Adolescents With Obesity and Obstructive Sleep Disorders NOT_YET_RECRUITING NCT04121923 Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea COMPLETED NCT02703207 Neurocognitive and Health Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD RECRUITING NCT05977296 Obstructive Sleep Apnea (OSA), Oral Frailty, Dysphagia, Continuous Positive Airway Pressure (CPAP) COMPLETED NCT07600333 CPAP vs High-Flow Nasal Cannula for Treating Sleep Apnea in Children NOT_YET_RECRUITING NCT07595185 Effects of Accelerated rTMS on Sleep Architecture in Chronic Insomnia Disorder NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41623865 Case Report: Hypertensive encephalopathy presents with complex types of sleep breathing events. Frontiers in cardiovascular medicine (2025)

Related Devices (Code: LQZ)

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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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