FDA 510(k) Application Details - K201376

Device Classification Name	More FDA Info for this Device
510(K) Number	K201376
Device Name	ANAM Test System
Applicant	Vista LifeSciences, Inc. 7375 S. Peoria St. Suite 210 Englewood, CO 80112 US Other 510(k) Applications for this Company
Contact	Margaret E. Molloy Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	POM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/26/2020
Decision Date	03/25/2021
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