FDA 510(k) Application Details - K203546

Device Classification Name	More FDA Info for this Device
510(K) Number	K203546
Device Name	gammaCore Sapphire
Applicant	Electrocore, Inc. 150 Allen Road, Suite 201 Basking Ridge, NJ 07920 US Other 510(k) Applications for this Company
Contact	Mike Romaniw Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PKR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/04/2020
Decision Date	02/12/2021
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