The following data is part of a premarket notification filed by Radionics, Inc. with the FDA for Epidural Peg Electrode (ep), Sphenoidal Electrode (eds) And Foramen, Ovale Depth Electrode (ed-fo) For Epilepsy Monitori.
| Device ID | K961942 |
| 510k Number | K961942 |
| Device Name: | EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND FORAMEN, OVALE DEPTH ELECTRODE (ED-FO) FOR EPILEPSY MONITORI |
| Classification | Electrode, Cortical |
| Applicant | RADIONICS, INC. P.O. BOX 438 22 TERRY AVENUE Burlington, MA 01803 -2591 |
| Contact | Amy J Laforte |
| Correspondent | Amy J Laforte RADIONICS, INC. P.O. BOX 438 22 TERRY AVENUE Burlington, MA 01803 -2591 |
| Product Code | GYC |
| CFR Regulation Number | 882.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-20 |
| Decision Date | 1997-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M272EDSEP1 | K961942 | 000 |
| M27240M081 | K961942 | 000 |