FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
C.C. Life 21
K Number: K230459
·
Decision Oct 19, 2023
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
77
Applicant Total
2
Review Days
240
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Basic Information
- Device Name
- C.C. Life 21
- K Number
- K230459
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- 21 Equipment S.R.L.
- Date Received
- February 21, 2023
- Decision Date
- October 19, 2023
- Product Code
- NFO
- 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 |
|---|---|---|---|
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | FDA class 2 | Neurology |
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Other Clearances by 21 Equipment S.R.L.
| K Number | Device Name | ||
|---|---|---|---|
| K213295 | C.C. LIFE 21 | Nov 17, 2022 | Substantially Equivalent |