FDA 510(k) Applications for Medical Device Product Code: PKR ()

FDA 510(k) Applications for Medical Device Product Code "PKR"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K182369	Electrocore, Inc.	gammaCore Sapphire	11/27/2018
K191830	Electrocore, Inc.	gammaCore Sapphire	03/26/2020
K203546	Electrocore, Inc.	gammaCore Sapphire	02/12/2021
K211856	Electrocore, Inc.	gammaCore Sapphire	09/10/2021
DEN150048	electroCore, LLC	gammaCore Non-invasive Vagus Nerve Stimulator	04/14/2017
K180538	electroCore, LLC	gammaCore Sapphire	03/30/2018
K171306	electroCore, LLC	gammaCore-S	05/30/2017
K173442	electroCore, LLC	gammaCore-S	01/23/2018
K172270	eletroCore, LLC	gammaCore-2	12/07/2017