Company ยท US
Blackrock Microsystems
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2021. Name variants (Inc, Corp, punctuation) are merged.
3510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 10, 2021 | K202174 | Digital NeuroPort Biopotential Signal Processing System Blackrock Microsystems | GWL |
| Feb 14, 2020 | K191346 | Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) Blackrock Microsystems | GYC |
| Feb 9, 2011 | K110010 | NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM Blackrock Microsystems, Inc. | GZL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 8, 2016 | Blackrock Microsystems, LLC Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes within corrugated cartons.
Product Usage:
The Blackrock NeuroPort Biopotential Signal Processing System supports recording, pr Terminated |
GWL | K090957 |
| Sep 8, 2016 | Blackrock Microsystems, LLC Neural Signal Amplifier. Part Numbers: 4208, 5703, 5749, 5748, 5747.
Product Usage:
The Blackrock NeuroPort Biopotential Signal Processing System supports recording, processing and display of biopote Terminated |
GWL | K090957 |