FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Elexir
K Number: K211380
·
Decision Jul 30, 2021
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
17
Applicant Total
5
Review Days
87
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Basic Information
- Device Name
- Elexir
- K Number
- K211380
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5891
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nu Eyne Co., Ltd.
- Date Received
- May 4, 2021
- Decision Date
- July 30, 2021
- Product Code
- PCC
- 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 |
|---|---|---|---|
| PCC | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | FDA class 2 | Neurology |
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