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FDA 510(k)

Happy Health Home Sleep Test

K-Number: K242224 · 2025-06-18

ApplicantHappy Health, Inc.
Decision Date2025-06-18
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Happy Health Home Sleep Test is the device name listed in this FDA 510(k) record. The listed applicant is Happy Health, Inc.. It received FDA 510(k) clearance on 2025-06-18 under 510(k) number K242224. 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 Happy Health Home Sleep Test?

Happy Health Home Sleep Test is a medical device that received FDA 510(k) clearance on 2025-06-18. The listed applicant is Happy Health, Inc.. The 510(k) number is K242224.

When did Happy Health Home Sleep Test receive FDA 510(k) clearance?

Happy Health Home Sleep Test received FDA 510(k) clearance on 2025-06-18, under 510(k) number K242224.

Who is the listed applicant for Happy Health Home Sleep Test?

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

What is the FDA product code for Happy Health Home Sleep Test?

The FDA product code for Happy Health Home Sleep Test 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.

NCT06938672Evaluating the Effects of tDCS on Sleep and Cognition in Healthy Older AdultsCOMPLETEDNCT07778121Screening for Obstructive Sleep Apnea in High-risk Patients in a Danish Rural Population: A Pilot Feasibility StudyRECRUITING

Other records listing Happy Health, Inc. 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.

K240236Happy Ring Health Monitoring System

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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