The following data is part of a premarket notification filed by Radionics, Inc. with the FDA for Cortical Surf Epilepsy Elect Depth Elec Epilep Mon.
| Device ID | K926424 |
| 510k Number | K926424 |
| Device Name: | CORTICAL SURF EPILEPSY ELECT DEPTH ELEC EPILEP MON |
| 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 | 1992-12-23 |
| Decision Date | 1993-11-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M272AU8D5L251 | K926424 | 000 |
| M272AU12D5L251 | K926424 | 000 |
| M272AU4D10L251 | K926424 | 000 |
| M272AU4D10L51 | K926424 | 000 |
| M272AU4D5L251 | K926424 | 000 |
| M272AU6D10L251 | K926424 | 000 |
| M272AU6D10L51 | K926424 | 000 |
| M272AU6D5L251 | K926424 | 000 |
| M272AU8D10L251 | K926424 | 000 |
| M272AU8D10L51 | K926424 | 000 |
| M272AU10D5L251 | K926424 | 000 |