FDA 510(k) Application Details - K231141

Device Classification Name	More FDA Info for this Device
510(K) Number	K231141
Device Name	STarFix Designer Software C0265
Applicant	FHC, Inc. 1201 Main Street Bowdoin, ME 04287 US Other 510(k) Applications for this Company
Contact	Kelly Moeykens Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QRI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/21/2023
Decision Date	09/08/2023
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