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FDA 510(k)

NOA Sleep Apnea and Snoring Device

K-Number: K202651 · 2021-02-12

ApplicantOrthoapnea S.L.
Decision Date2021-02-12
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NOA Sleep Apnea and Snoring Device is a medical device manufactured by Orthoapnea S.L.. It received FDA 510(k) clearance on 2021-02-12 under approval number K202651. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOA Sleep Apnea and Snoring Device?

NOA Sleep Apnea and Snoring Device is a medical device that received FDA 510(k) clearance on 2021-02-12. It is manufactured by Orthoapnea S.L.. The 510(k) number is K202651.

When was NOA Sleep Apnea and Snoring Device approved by the FDA?

NOA Sleep Apnea and Snoring Device received FDA 510(k) clearance on 2021-02-12, under approval number K202651.

What company makes NOA Sleep Apnea and Snoring Device?

NOA Sleep Apnea and Snoring Device is manufactured by Orthoapnea S.L..

What is the FDA product code for NOA Sleep Apnea and Snoring Device?

The FDA product code for NOA Sleep Apnea and Snoring Device is LRK.

Related Clinical Trials

NCT02193425 Reliability of the Human Brain Connectome COMPLETED NCT07606495 Impact on Prognosis of Increased Sleep Quality Obtained by Personalized Night-time Nursing Care in Critically Ill Patients NOT_YET_RECRUITING NCT07613944 Ultrasound Assessment of Tongue Characteristics in Adolescents With Obesity and Obstructive Sleep Disorders NOT_YET_RECRUITING NCT03288207 Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments RECRUITING NCT07611643 Bruxism Therapy of Facial Pain RECRUITING NCT04121923 Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea COMPLETED

Related PubMed Literature

PMID: 41623865 Case Report: Hypertensive encephalopathy presents with complex types of sleep breathing events. Frontiers in cardiovascular medicine (2025) PMID: 40290478 Mental health apps in India: regulatory landscape and future directions. BJPsych international (2025)

Other Devices by Orthoapnea S.L.

K203477Classic

Related Devices (Code: LRK)

K162192BlueProBluesom K152660HYPNOSPADSomnics, Inc. K161832O2VENT TOventus Manufacturing Pty, Ltd. K162306SomnoDent ALPHASomnomed, Inc. K160531NoiselezzFirma Ingemarsson K153200SnoreRxApnea Sciences Corporation

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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