FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
gammaCore Sapphire
K Number: K211856
·
Decision Sep 10, 2021
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
8
Applicant Total
4
Review Days
86
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Basic Information
- Device Name
- gammaCore Sapphire
- K Number
- K211856
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5892
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Electrocore, Inc.
- Date Received
- June 16, 2021
- Decision Date
- September 10, 2021
- 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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