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 IDK211856
510k NumberK211856
Device Name:GammaCore Sapphire
ClassificationNon-invasive Vagus Nerve Stimulator - Headache
Applicant Electrocore, Inc. 200 Forge Way, Suite 205 Rockaway,  NJ  07866
ContactMike Romaniw
CorrespondentMike Romaniw
Electrocore, Inc. 200 Forge Way, Suite 205 Rockaway,  NJ  07866
Product CodePKR  
CFR Regulation Number882.5892 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-06-16
Decision Date2021-09-10

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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