FDA 510(k) Applications Submitted by Mike Romaniw

FDA 510(k) Number Submission Date Device Name Applicant
K180538 02/28/2018 gammaCore Sapphire electroCore, LLC
K171306 05/03/2017 gammaCore-S electroCore, LLC
K211856 06/16/2021 gammaCore Sapphire Electrocore, Inc.
K191830 07/09/2019 gammaCore Sapphire Electrocore, Inc.
K172270 07/28/2017 gammaCore-2 eletroCore, LLC
K182369 08/31/2018 gammaCore Sapphire Electrocore, Inc.
DEN150048 10/16/2015 gammaCore Non-invasive Vagus Nerve Stimulator electroCore, LLC
K173442 11/06/2017 gammaCore-S electroCore, LLC
K203546 12/04/2020 gammaCore Sapphire Electrocore, Inc.


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