The following data is part of a premarket notification filed by Blackrock Neuromed with the FDA for Cervello Stim.
| Device ID | K151354 |
| 510k Number | K151354 |
| Device Name: | Cervello STIM |
| Classification | Electrode, Cortical |
| Applicant | BLACKROCK NEUROMED 630 KOMAS DRIVE, SUITE 200 Salt Lake City, UT 84108 |
| Contact | Shanna Ryan |
| Correspondent | John Ziobro SPECTRAMEDEX 117 WEST SOUTH STREET Oconomowo, WI 53066 |
| Product Code | GYC |
| CFR Regulation Number | 882.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-20 |
| Decision Date | 2016-01-27 |
| Summary: | summary |