Electrocore L L C

FDA Filings

This page includes the latest FDA filings for Electrocore L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3009060963
• FEI Number: 3009060963
• Name: ELECTROCORE LLC
• Owner & Operator: ElectroCore, Inc.
• Contact Address: 150 Allen Road Suite 201; Basking Ridge NJ 07920 US
• Official Correspondent:
  • Michael Romaniw
  • x-973-3556702-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 150 Allen Rd Ste 201 ; Basking Ridge, NJ 07920 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 00815203021833 ELECTROCORE, LLC	gammaCore Sapphire SLC DEMO Refill Card Kit 12016-04562	2021-08-12
GUDID 00815203021826 ELECTROCORE, LLC	gammaCore Sapphire SLC DEMO Refill Card Kit 12016-04562	2021-08-12
GUDID 00815203021819 ELECTROCORE, LLC	gammaCore Sapphire DEMO Refill Card Kit 14016-04505	2021-08-12
GUDID 00815203021802 ELECTROCORE, LLC	gammaCore Sapphire DEMO Refill Card Kit 14016-04504	2021-08-12
GUDID 00815203021796 ELECTROCORE, LLC	gammaCore Sapphire Refill Card Kit 14016-04503	2021-08-12
GUDID 00815203021789 ELECTROCORE, LLC	gammaCore Sapphire Refill Card Kit 14016-04502	2021-08-12
GUDID 00815203021772 ELECTROCORE, LLC	gammaCore Sapphire Refill Card Kit 14016-04501	2021-08-12
GUDID 00815203021765 ELECTROCORE, LLC	gammaCore Sapphire SLC DEMO Device Kit 14016-04004	2021-08-12
GUDID 00815203021758 ELECTROCORE, LLC	gammaCore Sapphire SLC DEMO Device Kit 14016-04003	2021-08-12
GUDID 00815203021741 ELECTROCORE, LLC	gammaCore Sapphire SLC Device Kit 14016-04002	2021-08-12
GUDID 00815203021734 ELECTROCORE, LLC	gammaCore Sapphire SLC Device Kit 14016-04001	2021-08-12
GUDID 00815203021529 ELECTROCORE, LLC	gammaCore Sapphire DEMO Refill Card Kit 13016-04507	2021-08-12
GUDID 00815203021512 ELECTROCORE, LLC	gammaCore Sapphire DEMO Refill Card Kit 13016-04506	2021-08-12
GUDID 00815203021505 ELECTROCORE, LLC	gammaCore Sapphire DEMO Refill Card Kit 13016-04505	2021-08-12
GUDID 00815203021499 ELECTROCORE, LLC	gammaCore Sapphire Refill Card Kit 13016-04504	2021-08-12
GUDID 00815203021482 ELECTROCORE, LLC	gammaCore Sapphire Refill Card Kit 13016-04503	2021-08-12
GUDID 00815203021475 ELECTROCORE, LLC	gammaCore Sapphire Refill Card Kit 13016-04502	2021-08-12
GUDID 00815203021468 ELECTROCORE, LLC	gammaCore Sapphire Refill Card Kit 13016-04501	2021-08-12
GUDID 00815203021345 ELECTROCORE, LLC	gammaCore Sapphire SLC DEMO Device Kit 13016-04009	2021-08-12
GUDID 00815203021338 ELECTROCORE, LLC	gammaCore Sapphire SLC DEMO Device Kit 13016-04008	2021-08-12
GUDID 00815203021321 ELECTROCORE, LLC	gammaCore Sapphire SLC DEMO Device Kit 13016-04007	2021-08-12
GUDID 00815203021314 ELECTROCORE, LLC	gammaCore Sapphire SLC DEMO Device Kit 13016-04006	2021-08-12
GUDID 00815203021307 ELECTROCORE, LLC	gammaCore Sapphire Device Starter Kit 13016-04005	2021-08-12
GUDID 00815203021291 ELECTROCORE, LLC	gammaCore Sapphire Device Starter Kit 13016-04004	2021-08-12
GUDID 00815203021284 ELECTROCORE, LLC	gammaCore Sapphire Device Starter Kit 13016-04003	2021-08-12
GUDID 00815203021277 ELECTROCORE, LLC	gammaCore Sapphire Device Starter Kit 13016-04002	2021-08-12
GUDID 00815203021260 ELECTROCORE, LLC	gammaCore Sapphire Device Starter Kit 13016-04001	2021-08-12
GUDID 00815203020621 ELECTROCORE, LLC	gammaCore Sapphire SLC Refill Card Kit 12016-04593	2021-08-12
GUDID 00815203020614 ELECTROCORE, LLC	gammaCore Sapphire SLC Refill Card Kit 12016-04531	2021-08-12
GUDID 00815203020560 ELECTROCORE, LLC	gammaCore Sapphire SLC DEMO Device Kit 12016-04004	2021-08-12
GUDID 00815203020553 ELECTROCORE, LLC	gammaCore Sapphire SLC DEMO Device Kit 12016-04003	2021-08-12
GUDID 00815203020546 ELECTROCORE, LLC	gammaCore Sapphire SLC Device Kit 12016-04002	2021-08-12
GUDID 00815203020539 ELECTROCORE, LLC	gammaCore Sapphire SLC Device Kit 12016-04001	2021-08-12
GUDID 00815203020423 ELECTROCORE, LLC	gammaCore Sapphire 3 11016-40301	2019-10-23
GUDID 00815203020133 ELECTROCORE, LLC	gammaCore Sapphire 10016-40303	2019-10-23
GUDID 00815203020126 ELECTROCORE, LLC	gammaCore-2 10016-40312	2019-10-23
GUDID 00815203020119 ELECTROCORE, LLC	gammaCore-2 10016-40311	2019-10-23
GUDID 00815203020102 ELECTROCORE, LLC	gammaCore-2 10016-40310	2019-10-23
GUDID 00815203020065 ELECTROCORE, LLC	gammaCore Refill Card 93-Day 10016-43193	2019-10-23
GUDID 00815203020058 ELECTROCORE, LLC	gammaCore Refill Card 31-Day 10016-43131	2019-10-23
GUDID 00815203020041 ELECTROCORE, LLC	gammaCore Refill Card 10-Day 10016-43110	2019-10-23
GUDID 00815203020034 ELECTROCORE, LLC	gammaCore Sapphire 10016-40302	2019-10-23
GUDID 00815203020027 ELECTROCORE, LLC	gammaCore Sapphire 10016-40301	2019-10-23
GUDID 00815203020010 ELECTROCORE, LLC	gammaCore-S 10009-40601	2019-10-23
PMN K180538 ElectroCore, LLC	GammaCore Sapphire	2018-03-30
PMN K173442 ElectroCore, LLC	GammaCore-S	2018-01-23
PMN K171306 | PKR ELECTROCORE LLC [ElectroCore, Inc.]	gammaCore-S	2017-06-28
PMN K171306 | PKR ELECTROCORE LLC [ElectroCore, Inc.]	gammaCore-2	2017-06-28
PMN K171306 | PKR ELECTROCORE LLC [ElectroCore, Inc.]	gammaCore Sapphire	2017-06-28
PMN DEN150048 | PKR ELECTROCORE LLC [ElectroCore, Inc.]	gammaCore	2017-06-28
PMN K171306 ElectroCore, LLC	GammaCore-S	2017-05-30
De Novo DEN150048 ElectroCore, LLC	GammaCore Non-invasive Vagus Nerve Stimulator	2017-04-14

Related Finance Registrations

SEC

0001560258

ElectroCore, LLC of DELAWARE