FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SAVI Dual (TM) Migraine Therapy
K Number: K230358
·
Decision May 16, 2023
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
5
Applicant Total
3
Review Days
95
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Basic Information
- Device Name
- SAVI Dual (TM) Migraine Therapy
- K Number
- K230358
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.5808
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Eneura, Inc.
- Date Received
- February 10, 2023
- Decision Date
- May 16, 2023
- Product Code
- OKP
- 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 |
|---|---|---|---|
| OKP | Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache | FDA class 2 | Neurology |
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