FDA 510(k) Application Details - K191700

Device Classification Name	Stimulator, Mechanical, Evoked Response   More FDA Info for this Device
510(K) Number	K191700
Device Name	Stimulator, Mechanical, Evoked Response
Applicant	Blinktbi Inc. 635 Rutledge Ave., Suite 102 Charleston, SC 29403 US Other 510(k) Applications for this Company
Contact	Ryan Fiorini Other 510(k) Applications for this Contact
Regulation Number	882.1880   More FDA Info for this Regulation Number
Classification Product Code	GZP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/25/2019
Decision Date	12/09/2019
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