FDA 510(k) Application Details - K212425

Device Classification Name	More FDA Info for this Device
510(K) Number	K212425
Device Name	MicroTrend System
Applicant	ExoStat Medical, Inc. 14162 Commerce Ave. NE, Suite 100 Prior Lake, MN 55372-1480 US Other 510(k) Applications for this Company
Contact	Irvin Pierskalla Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/04/2021
Decision Date	11/07/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review