FDA 510(k) Application Details - K233230

Device Classification Name	More FDA Info for this Device
510(K) Number	K233230
Device Name	See Factor CT3Ö
Applicant	Epica International, Inc. 1875 East Main St., Spark Warehouse 92, Dock 12 & 13 Duncan, SC 29334 US Other 510(k) Applications for this Company
Contact	Craig Glaiberman Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/28/2023
Decision Date	06/21/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review