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FDA 510(k)

Huxley SANSA Home Sleep Apnea Test (1000-00)

K-Number: K240285 · 2024-07-15

ApplicantHuxley Medical
Decision Date2024-07-15
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Huxley SANSA Home Sleep Apnea Test (1000-00) is a medical device manufactured by Huxley Medical. It received FDA 510(k) clearance on 2024-07-15 under approval number K240285. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Huxley SANSA Home Sleep Apnea Test (1000-00)?

Huxley SANSA Home Sleep Apnea Test (1000-00) is a medical device that received FDA 510(k) clearance on 2024-07-15. It is manufactured by Huxley Medical. The 510(k) number is K240285.

When was Huxley SANSA Home Sleep Apnea Test (1000-00) approved by the FDA?

Huxley SANSA Home Sleep Apnea Test (1000-00) received FDA 510(k) clearance on 2024-07-15, under approval number K240285.

What company makes Huxley SANSA Home Sleep Apnea Test (1000-00)?

Huxley SANSA Home Sleep Apnea Test (1000-00) is manufactured by Huxley Medical.

What is the FDA product code for Huxley SANSA Home Sleep Apnea Test (1000-00)?

The FDA product code for Huxley SANSA Home Sleep Apnea Test (1000-00) is MNR.

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)

Other Devices by Huxley Medical

K252497SANSA HSAT K250882SANSA HSAT K244027SANSA HSAT

Related Devices (Code: MNR)

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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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