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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 the device name listed in this FDA 510(k) record. The listed applicant is Huxley Medical. It received FDA 510(k) clearance on 2024-07-15 under 510(k) 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. The listed applicant is Huxley Medical. The 510(k) number is K240285.

When did Huxley SANSA Home Sleep Apnea Test (1000-00) receive FDA 510(k) clearance?

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

Who is the listed applicant for Huxley SANSA Home Sleep Apnea Test (1000-00)?

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

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

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.

NCT06050720Sleep Apnoea Breathing Record Exploratory Study (SABRES)COMPLETEDNCT06949969Alesis OSA-1 Obstructive Sleep Apnea TreatmentCOMPLETEDNCT07530523KPAP vs EPR for EfficacyNOT_YET_RECRUITINGNCT07744581Efficacy and Accuracy of an AI-Driven Sleep Earbud for Chronic InsomniaACTIVE_NOT_RECRUITINGNCT07751562KPAP vs AirSense 11 With EPRNOT_YET_RECRUITINGNCT07778121Screening for Obstructive Sleep Apnea in High-risk Patients in a Danish Rural Population: A Pilot Feasibility StudyRECRUITING

Other records listing Huxley Medical as applicant

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.

K252497SANSA HSATK250882SANSA HSATK244027SANSA HSAT

Related Devices (Code: MNR)

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.

K254042WatchPAT SWItamar Medical , Ltd.K260050WRAP SystemHuneo, LLCK253148RX-1 SleepVivaquant, Inc. Dba Rhythm ExpressK252628CASSIEWesper, Inc.K252497SANSA HSATHuxley MedicalK250882SANSA HSATHuxley Medical

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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