FDA 510(k) Application Details - K231546

Device Classification Name	Ventilatory Effort Recorder   More FDA Info for this Device
510(K) Number	K231546
Device Name	Ventilatory Effort Recorder
Applicant	Compumedics Limited 30-40 Flockhart St Abbotsford 3067 AU Other 510(k) Applications for this Company
Contact	Michael Frischman 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	05/30/2023
Decision Date	11/30/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review