Medical Device Manufacturer · US , Basking Ridge , NJ

Electrocore, LLC - FDA 510(k) Cleared Devices

4 submissions · 3 cleared · Since 2017
4
Total
3
Cleared
1
Denied
FDA 510(k) Regulatory Record - Electrocore, LLC Neurology ✕
4 devices
1-4 of 4
Cleared Mar 30, 2018
gammaCore Sapphire
K180538 · PKR
Neurology · 30d
Cleared Jan 23, 2018
gammaCore-S
K173442 · PKR
Neurology · 78d
Cleared May 30, 2017
gammaCore-S
K171306 · PKR
Neurology · 27d
Not Cleared Apr 14, 2017
gammaCore Non-invasive Vagus Nerve Stimulator
DEN150048 · PKR
Neurology · 546d
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