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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilatory Effort Recorder
510(k) Number K242224
Device Name Happy Health Home Sleep Test
Applicant
Happy Health, Inc.
3200 Gracie Kiltz Ln., #301
Austin,  TX  78758
Applicant Contact Dustin Freckleton
Correspondent
Rx Device Consulting
7 Ct.yard Pl.
Lexington,  MA  02420
Correspondent Contact Rakesh Lal
Regulation Number868.2375
Classification Product Code
MNR  
Subsequent Product Code
OMC  
Date Received07/29/2024
Decision Date 06/18/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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