The following data is part of a premarket notification filed by Impulse Systems, Inc. with the FDA for Impulse Epidural Electrode.
| Device ID | K884663 |
| 510k Number | K884663 |
| Device Name: | IMPULSE EPIDURAL ELECTRODE |
| Classification | Device, Nerve Conduction Velocity Measurement |
| Applicant | IMPULSE SYSTEMS, INC. 124 VISTA RD. Madison, WI 53705 |
| Contact | Raymond T Riddle |
| Correspondent | Raymond T Riddle IMPULSE SYSTEMS, INC. 124 VISTA RD. Madison, WI 53705 |
| Product Code | JXE |
| CFR Regulation Number | 882.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-07 |
| Decision Date | 1989-01-17 |