The following data is part of a premarket notification filed by Radionics, Inc. with the FDA for Ojemann Cortical Stimulator.
| Device ID | K924226 |
| 510k Number | K924226 |
| Device Name: | OJEMANN CORTICAL STIMULATOR |
| Classification | Electrode, Cortical |
| Applicant | RADIONICS, INC. P.O. BOX 438 76 CAMBRIDGE STREET Burlington, MA 01803 -0738 |
| Contact | Linda Jalbert |
| Correspondent | Linda Jalbert RADIONICS, INC. P.O. BOX 438 76 CAMBRIDGE STREET Burlington, MA 01803 -0738 |
| Product Code | GYC |
| CFR Regulation Number | 882.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-21 |
| Decision Date | 1993-04-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M272OCS2PND1 | K924226 | 000 |