gammaCore-S— 510(k) K173442

Substantially Equivalent

Electrocore, LLC

FDA 510(k) clearance K173442 for gammaCore-S, Substantially Equivalent on 2018-01-23. Applicant: Electrocore, LLC. Device class: 2.

Clearance details

Applicant: Electrocore, LLC
Product code: Code PKR
Device class: Class 2
Regulation: 21 CFR 882.5892
Advisory panel: Neurology
Date received: 2017-11-06
Decision date: 2018-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Basking Ridge, NJ, US

Download summary PDF View on FDA.gov ↗

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