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 a medical device manufactured by Eletrocore, LLC. It received FDA 510(k) clearance on 2017-12-07 under approval 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. It is manufactured by Eletrocore, LLC. The 510(k) number is K172270.
When was gammaCore-2 approved by the FDA?
gammaCore-2 received FDA 510(k) clearance on 2017-12-07, under approval number K172270.
What company makes gammaCore-2?
gammaCore-2 is manufactured by Eletrocore, LLC.
What is the FDA product code for gammaCore-2?
The FDA product code for gammaCore-2 is PKR.
Related Devices (Code: PKR)
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.