GammaCore Sapphire

Non-invasive Vagus Nerve Stimulator - Headache

Electrocore, Inc.

The following data is part of a premarket notification filed by Electrocore, Inc. with the FDA for Gammacore Sapphire.

Pre-market Notification Details

Device IDK203546
510k NumberK203546
Device Name:GammaCore Sapphire
ClassificationNon-invasive Vagus Nerve Stimulator - Headache
Applicant Electrocore, Inc. 150 Allen Road, Suite 201 Basking Ridge,  NJ  07920
ContactMike Romaniw
CorrespondentMike Romaniw
Electrocore, Inc. 150 Allen Road, Suite 201 Basking Ridge,  NJ  07920
Product CodePKR  
CFR Regulation Number882.5892 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-04
Decision Date2021-02-12

Trademark Results [GammaCore Sapphire]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GAMMACORE SAPPHIRE
GAMMACORE SAPPHIRE
87519426 5897664 Live/Registered
Electrocore LLC
2017-07-07

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