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FDA 510(k)

gammaCore-S

K-Number: K171306 · 2017-05-30

ApplicantElectrocore, LLC
Decision Date2017-05-30
Product CodePKR
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

gammaCore-S is a medical device manufactured by Electrocore, LLC. It received FDA 510(k) clearance on 2017-05-30 under approval number K171306. The device is classified under product code PKR. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the gammaCore-S?

gammaCore-S is a medical device that received FDA 510(k) clearance on 2017-05-30. It is manufactured by Electrocore, LLC. The 510(k) number is K171306.

When was gammaCore-S approved by the FDA?

gammaCore-S received FDA 510(k) clearance on 2017-05-30, under approval number K171306.

What company makes gammaCore-S?

gammaCore-S is manufactured by Electrocore, LLC.

What is the FDA product code for gammaCore-S?

The FDA product code for gammaCore-S is PKR.

Other Devices by Electrocore, LLC

DEN150048gammaCore Non-invasive Vagus Nerve Stimulator K180538gammaCore Sapphire K173442gammaCore-S

Related Devices (Code: PKR)

K172270gammaCore-2Eletrocore, LLC DEN150048gammaCore Non-invasive Vagus Nerve StimulatorElectrocore, LLC K182369gammaCore SapphireElectrocore, Inc. K180538gammaCore SapphireElectrocore, LLC K173442gammaCore-SElectrocore, LLC K191830gammaCore SapphireElectrocore, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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