Blackrock Microsystems, LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 3
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2763-2016 | Class II | Neural Signal Amplifier. Part Numbers: 4208, 5703, 5749, 5748, 5747. Product Usage: The Blackroc | August 10, 2016 |
| Z-2764-2016 | Class II | Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes within corrugated cartons. | August 10, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K202174 | Digital NeuroPort Biopotential Signal Processing System | February 10, 2021 |
| K191346 | Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) | February 14, 2020 |
| K110010 | NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM | February 9, 2011 |