FDA 510(k) Application Details - K243513

Device Classification Name	Device, Sleep Assessment   More FDA Info for this Device
510(K) Number	K243513
Device Name	Device, Sleep Assessment
Applicant	PneumoWave, Ltd Suites 3 and 4, Second Floor, Maxim 3 Maxim Office Park, Parklands Avenue Eurocentral ML1 4WQ GB Other 510(k) Applications for this Company
Contact	Stuart Kelly Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LEL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/2024
Decision Date	04/16/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review