FDA 510(k) Application Details - K183047

Device Classification Name	Stimulator, Spinal-Cord, Implanted (Pain Relief)   More FDA Info for this Device
510(K) Number	K183047
Device Name	Stimulator, Spinal-Cord, Implanted (Pain Relief)
Applicant	Nalu Medical, Inc 1525 Faraday Ave. Suite 180 Carlsbad, CA 92008 US Other 510(k) Applications for this Company
Contact	Michele Chin-Purcell Other 510(k) Applications for this Contact
Regulation Number	882.5880   More FDA Info for this Regulation Number
Classification Product Code	GZB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/02/2018
Decision Date	03/22/2019
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