FDA 510(k) Application Details - K182706

Device Classification Name	More FDA Info for this Device
510(K) Number	K182706
Device Name	External upper limb tremor stimulator
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	09/27/2018
Decision Date	10/25/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review