K202174 is an FDA 510(k) clearance for the Digital NeuroPort Biopotential Signal Processing System. This device is classified as a Amplifier, Physiological Signal (Class II - Special Controls, product code GWL).
Submitted by Blackrock Microsystems (Salt Lake City, US). The FDA issued a Cleared decision on February 10, 2021, 190 days after receiving the submission on August 4, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1835.
| 510(k) Number | K202174 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 04, 2020 |
| Decision Date | February 10, 2021 |
| Days to Decision | 190 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GWL - Amplifier, Physiological Signal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1835 |