FDA 510(k) Application Details - DEN170028

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN170028
Device Name	Cala ONE
Applicant	Cala Health, Inc. 875 Mahler Road. Suite 168 Burlingame, CA 94010 US Other 510(k) Applications for this Company
Contact	Scott A. Wilson 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	05/17/2017
Decision Date	04/26/2018
Decision	DENG -
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review