gammaCore-S— 510(k) K171306
Substantially EquivalentElectrocore, LLC
FDA 510(k) clearance K171306 for gammaCore-S, Substantially Equivalent on 2017-05-30. 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Basking Ridge, NJ, US
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