FDA 510(k) Application Details - K242447

Device Classification Name	Standard Polysomnograph With Electroencephalograph   More FDA Info for this Device
510(K) Number	K242447
Device Name	Standard Polysomnograph With Electroencephalograph
Applicant	Compumedics Limited 30-40 Flockhart St Abbotsford 3067 AU Other 510(k) Applications for this Company
Contact	John Joseph Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OLV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/16/2024
Decision Date	02/20/2025
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	Y
Expedited Review