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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 the device name listed in this FDA 510(k) record. The listed applicant is Achaemenid, LLC. It received FDA 510(k) clearance on 2023-07-12 under 510(k) 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. The listed applicant is Achaemenid, LLC. The 510(k) number is K230532.

When did RADx Intraoral Appliance for Snoring and Sleep Apnea receive FDA 510(k) clearance?

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

Who is the listed applicant for RADx Intraoral Appliance for Snoring and Sleep Apnea?

The FDA 510(k) record lists Achaemenid, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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.

NCT06960200Phototherapy for Non-responders to Oral Appliance Therapy for Obstructive Sleep ApneaRECRUITINGNCT04092660Increasing the Use of an Anti-snoring Mouth Guard (Mandibular Advancement Appliance) to Prevent Upper Airway Collapse During Sleep in Patients With Obstructive Sleep Apnoea.RECRUITINGNCT05477719Effect of Compression Stockings on the Number of Apneas/Hypopneas Per Hour of Sleep in Patients With Syndrome Obstructive Sleep Apnea/Hypopnea as Compared to no TreatmentCOMPLETEDNCT05530265Effect of Smart Watch and App on PAP Adherence in OSA (Watch-OSA)COMPLETEDNCT06576310Predictive Factors for Occlusal Changes in Obstructive Sleep Apnea Treatment With Mandibular Advancement ApplianceRECRUITINGNCT06587256Study to Examine the Effect of Silicone Mouth Tape on Snoring and Mild Sleep Apnea.RECRUITING

Related Devices (Code: LQZ)

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.

K233754AIO BreatheAiomega, LLCK203712The SlideBiotex, Inc.K191320Slow Wave DS8Slow Wave, Inc.K192581The NightBlocks ApplianceAdvanced Facialdontics, LLCK162816SML-OSA2 AppliancesSelane Products, Inc.

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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