FDA 510(k) Application Details - K180173

Device Classification Name	Device, Biofeedback   More FDA Info for this Device
510(K) Number	K180173
Device Name	Device, Biofeedback
Applicant	Palo Alto Health Sciences, Inc. 12020 113th Ave NE, Building C, Suite 215 Kirkland, WA 98034 US Other 510(k) Applications for this Company
Contact	Simon Thomas Other 510(k) Applications for this Contact
Regulation Number	882.5050   More FDA Info for this Regulation Number
Classification Product Code	HCC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/22/2018
Decision Date	08/23/2018
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