FDA 510(k) Application Details - K203288

Device Classification Name	More FDA Info for this Device
510(K) Number	K203288
Device Name	Cala Trio
Applicant	Cala Health, Inc. 875 Mahler Road, Suite 168 Burlingame, CA 94010 US Other 510(k) Applications for this Company
Contact	Amanda Johnston Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QBC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/09/2020
Decision Date	10/05/2021
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