FDA 510(k) Application Details - K222237

Device Classification Name	More FDA Info for this Device
510(K) Number	K222237
Device Name	Cala kIQ
Applicant	Cala Health, Inc. 1800 Gateway Dr, Suite 300 San Mateo, CA 94404 US Other 510(k) Applications for this Company
Contact	Danielle McDonnell Boyd 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	07/26/2022
Decision Date	11/22/2022
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