BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM
FDA 510(k) clearance K090957 · decided 2009-05-28
Clearance details
- K-number
- K090957
- Device name
- BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM
- Applicant
- I2s Micro Implantable Systems, LLC
- Decision
- Substantially Equivalent
- Date received
- 2009-04-06
- Decision date
- 2009-05-28
- Days to decision
- 52 days
- Clearance type
- Abbreviated
- Product code
- GWL
- Device class
- 2
- Regulation number
- 882.1835
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Stoughton, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Neural Signal Amplifier. Part Numbers: 4208, 5703, 5749, 5748, 5747. Product Usage: The Bl recall (Z-2763-2016) | Blackrock Microsystems, LLC | 2016-09-08 |
| Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes within corrugated recall (Z-2764-2016) | Blackrock Microsystems, LLC | 2016-09-08 |