FDA 510(k) Application Details - K242224

Device Classification Name	Ventilatory Effort Recorder   More FDA Info for this Device
510(K) Number	K242224
Device Name	Ventilatory Effort Recorder
Applicant	Happy Health Inc. 3200 Gracie Kiltz Ln, #301 Austin, TX 78758 US Other 510(k) Applications for this Company
Contact	Dustin Freckleton Other 510(k) Applications for this Contact
Regulation Number	868.2375   More FDA Info for this Regulation Number
Classification Product Code	MNR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/29/2024
Decision Date	06/18/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review