The following data is part of a premarket notification filed by Instromedix, Inc. with the FDA for Neural Stimulator Monitor.
| Device ID | K833809 |
| 510k Number | K833809 |
| Device Name: | NEURAL STIMULATOR MONITOR |
| Classification | Stimulator, Spinal-cord, Implanted (pain Relief) |
| Applicant | INSTROMEDIX, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GZB |
| CFR Regulation Number | 882.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-02 |
| Decision Date | 1983-12-01 |