FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Digital NeuroPort Biopotential Signal Processing System
K Number: K202174
·
Decision Feb 10, 2021
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
52
Applicant Total
2
Review Days
190
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Basic Information
- Device Name
- Digital NeuroPort Biopotential Signal Processing System
- K Number
- K202174
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.1835
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Blackrock Microsystems
- Date Received
- August 4, 2020
- Decision Date
- February 10, 2021
- Product Code
- GWL
- 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 |
|---|---|---|---|
| GWL | Amplifier, Physiological Signal | FDA class 2 | Neurology |
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Other Clearances by Blackrock Microsystems
| K Number | Device Name | ||
|---|---|---|---|
| K191346 | Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) | Feb 14, 2020 | Substantially Equivalent |