gammaCore Sapphire
K-Number: K180538 · 2018-03-30
ApplicantElectrocore, LLC
Decision Date2018-03-30
Product CodePKR
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
gammaCore Sapphire is a medical device manufactured by Electrocore, LLC. It received FDA 510(k) clearance on 2018-03-30 under approval number K180538. 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 Sapphire?
gammaCore Sapphire is a medical device that received FDA 510(k) clearance on 2018-03-30. It is manufactured by Electrocore, LLC. The 510(k) number is K180538.
When was gammaCore Sapphire approved by the FDA?
gammaCore Sapphire received FDA 510(k) clearance on 2018-03-30, under approval number K180538.
What company makes gammaCore Sapphire?
gammaCore Sapphire is manufactured by Electrocore, LLC.
What is the FDA product code for gammaCore Sapphire?
The FDA product code for gammaCore Sapphire is PKR.
Related Clinical Trials
Other Devices by Electrocore, LLC
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.