The following data is part of a premarket notification filed by Blackrock Microsystems, Inc with the FDA for Neuroport Cortical Microelectrode Array System.
| Device ID | K110010 |
| 510k Number | K110010 |
| Device Name: | NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM |
| Classification | Electrode, Depth |
| Applicant | BLACKROCK MICROSYSTEMS, INC 391 CHIPETA WAY SUITE G Salt Lake City, UT 84108 |
| Contact | Jerry Alperin |
| Correspondent | Jerry Alperin BLACKROCK MICROSYSTEMS, INC 391 CHIPETA WAY SUITE G Salt Lake City, UT 84108 |
| Product Code | GZL |
| CFR Regulation Number | 882.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-03 |
| Decision Date | 2011-02-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814901020032 | K110010 | 000 |
| 00814901020025 | K110010 | 000 |