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510(k) K242224

Happy Health Home Sleep Test by Happy Health, Inc. — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2025
Date Received
July 29, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilatory Effort Recorder
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type

Other clearances by Happy Health, Inc.

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