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FDA 510(k)

gammaCore-2

K-Number: K172270 · 2017-12-07

ApplicantEletrocore, LLC
Decision Date2017-12-07
Product CodePKR
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

gammaCore-2 is the device name listed in this FDA 510(k) record. The listed applicant is Eletrocore, LLC. It received FDA 510(k) clearance on 2017-12-07 under 510(k) number K172270. 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-2?

gammaCore-2 is a medical device that received FDA 510(k) clearance on 2017-12-07. The listed applicant is Eletrocore, LLC. The 510(k) number is K172270.

When did gammaCore-2 receive FDA 510(k) clearance?

gammaCore-2 received FDA 510(k) clearance on 2017-12-07, under 510(k) number K172270.

Who is the listed applicant for gammaCore-2?

The FDA 510(k) record lists Eletrocore, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for gammaCore-2?

The FDA product code for gammaCore-2 is PKR.

Related Devices (Code: PKR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211856gammaCore SapphireElectrocore, Inc.K203546gammaCore SapphireElectrocore, Inc.K191830gammaCore SapphireElectrocore, Inc.K182369gammaCore SapphireElectrocore, Inc.K180538gammaCore SapphireElectrocore, LLCK173442gammaCore-SElectrocore, LLC

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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