FDA 510(k) Application Details - K143507

Device Classification Name	Device, Biofeedback   More FDA Info for this Device
510(K) Number	K143507
Device Name	Device, Biofeedback
Applicant	NFANT Labs, LLC 817 West Peachtree St Suite 320 Atlanta, GA 30308 US Other 510(k) Applications for this Company
Contact	Lou Malice 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	12/10/2014
Decision Date	09/09/2015
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