FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇹 Italy
LED PHOTIC System
K Number: K211974
·
Decision Sep 23, 2021
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
48
Applicant Total
4
Review Days
90
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Basic Information
- Device Name
- LED PHOTIC System
- K Number
- K211974
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Micromed S.P.A.
- Date Received
- June 25, 2021
- Decision Date
- September 23, 2021
- Product Code
- GWE
- 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 |
|---|---|---|---|
| GWE | Stimulator, Photic, Evoked Response | FDA class 2 | Neurology |
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