The following data is part of a premarket notification filed by Blackrock Microsystems with the FDA for Digital Neuroport Biopotential Signal Processing System.
| Device ID | K202174 |
| 510k Number | K202174 |
| Device Name: | Digital NeuroPort Biopotential Signal Processing System |
| Classification | Amplifier, Physiological Signal |
| Applicant | Blackrock Microsystems 630 Komas Drive, Suite 200 Salt Lake City, UT 84108 |
| Contact | Rachelle Frischknecht |
| Correspondent | Rachelle Frischknecht Blackrock Microsystems 630 Komas Drive, Suite 200 Salt Lake City, UT 84108 |
| Product Code | GWL |
| CFR Regulation Number | 882.1835 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-04 |
| Decision Date | 2021-02-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814901021404 | K202174 | 000 |
| 00814901021534 | K202174 | 000 |
| 00814901021473 | K202174 | 000 |
| 00814901021480 | K202174 | 000 |
| 00814901021435 | K202174 | 000 |
| 00814901021442 | K202174 | 000 |
| 00814901021343 | K202174 | 000 |
| 00814901021350 | K202174 | 000 |
| 00814901021367 | K202174 | 000 |
| 00814901021374 | K202174 | 000 |
| 00814901021381 | K202174 | 000 |
| 00814901021398 | K202174 | 000 |
| 00814901021527 | K202174 | 000 |