The following data is part of a premarket notification filed by Progress Mankind Technology with the FDA for Electrode For Neurological Surgery 2111.
| Device ID | K845035 |
| 510k Number | K845035 |
| Device Name: | ELECTRODE FOR NEUROLOGICAL SURGERY 2111 |
| Classification | Electrode, Cortical |
| Applicant | PROGRESS MANKIND TECHNOLOGY BOX 464 Hopkins, MN 55343 |
| Contact | Alfred A Iversen |
| Correspondent | Alfred A Iversen PROGRESS MANKIND TECHNOLOGY BOX 464 Hopkins, MN 55343 |
| Product Code | GYC |
| CFR Regulation Number | 882.1310 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-27 |
| Decision Date | 1985-07-30 |