FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
NEBA SYSTEM
K Number: DEN110019
·
Decision Jul 15, 2013
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
1
Review Days
585
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Basic Information
- Device Name
- NEBA SYSTEM
- K Number
- DEN110019
- Device Class
- FDA class 2
- Clearance Type
- Post-NSE
- Regulation Number
- 882.1440
- Medical Specialty
- Neurology
- Decision
- Unknown
- Applicant
- Lexicor Medical Technology, LLC
- Date Received
- December 8, 2011
- Decision Date
- July 15, 2013
- Product Code
- NCG
- 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 |
|---|---|---|---|
| NCG | Neuropsychiatric Interpretative Electroencephalograph Assessment Aid | FDA class 2 | Neurology |
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