Happy Health Home Sleep Test— 510(k) K242224

Name: FDA 510(k) clearance K242224
Creator: U.S. Food and Drug Administration
Published: 2025-06-18

Substantially Equivalent

Happy Health, Inc.

FDA 510(k) clearance K242224 for Happy Health Home Sleep Test, Substantially Equivalent on 2025-06-18. Applicant: Happy Health, Inc.. Device class: 2.

Clearance details

Applicant: Happy Health, Inc.
Product code: Code MNR
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2024-07-29
Decision date: 2025-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.