510(k) K090957 ยท GWL Amplifier, Physiological Signal
BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM
| Applicant | I2s Micro Implantable Systems, LLC, Stoughton WI, US |
| Decision | Substantially Equivalent, May 28, 2009 |
| Received | Apr 6, 2009 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K090957
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.