FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEUROPORT NEURAL SIGNAL PROCESSING SYSTEM
K Number: K060523
·
Decision Mar 28, 2006
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
27
Applicant Total
2
Review Days
29
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Basic Information
- Device Name
- NEUROPORT NEURAL SIGNAL PROCESSING SYSTEM
- K Number
- K060523
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cyberkinetics, Inc.
- Date Received
- February 27, 2006
- Decision Date
- March 28, 2006
- Product Code
- OMC
- 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 |
|---|---|---|---|
| OMC | Reduced- Montage Standard Electroencephalograph | FDA class 2 | Neurology |
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Other Clearances by Cyberkinetics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K042626 | NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM | Mar 28, 2005 | Substantially Equivalent |