FDA 510(k)
FDA class 2
Substantially Equivalent
🇷🇺 Russian Federation
Neuron-Spectrum-AM with Neuron-Spectrum.NET Software
K Number: K220254
·
Decision Nov 30, 2022
Classifications
1
FEI Numbers
68
Registration Numbers
68
Same Product Code
53
Applicant Total
3
Review Days
303
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Basic Information
- Device Name
- Neuron-Spectrum-AM with Neuron-Spectrum.NET Software
- K Number
- K220254
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Neurosoft , Ltd.
- Date Received
- January 31, 2022
- Decision Date
- November 30, 2022
- Product Code
- OLT
- 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 |
|---|---|---|---|
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | FDA class 2 | Neurology |
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