FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
gammaCore Non-invasive Vagus Nerve Stimulator
K Number: DEN150048
·
Decision Apr 14, 2017
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
8
Applicant Total
4
Review Days
546
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Basic Information
- Device Name
- gammaCore Non-invasive Vagus Nerve Stimulator
- K Number
- DEN150048
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 882.5892
- Medical Specialty
- Neurology
- Decision
- Unknown
- Applicant
- Electrocore, LLC
- Date Received
- October 16, 2015
- Decision Date
- April 14, 2017
- Product Code
- PKR
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PKR | Non-Invasive Vagus Nerve Stimulator - Headache | FDA class 2 | Neurology |
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