gammaCore Sapphire— 510(k) K182369
Substantially EquivalentElectrocore, Inc.
FDA 510(k) clearance K182369 for gammaCore Sapphire, Substantially Equivalent on 2018-11-27. Applicant: Electrocore, Inc.. Device class: 2.
Clearance details
- Applicant
- Electrocore, Inc.
- 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
- Traditional
- Location
- Basking Ridge, NJ, US
Recent devices under product code PKR
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