The following data is part of a premarket notification filed by Neuroscience, Inc. with the FDA for Somatosensory Evoked Potential Stimulator.
| Device ID | K855232 |
| 510k Number | K855232 |
| Device Name: | SOMATOSENSORY EVOKED POTENTIAL STIMULATOR |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | NEUROSCIENCE, INC. 210 TOPAZ ST. Milpitas, CA 95035 |
| Contact | John P Walker |
| Correspondent | John P Walker NEUROSCIENCE, INC. 210 TOPAZ ST. Milpitas, CA 95035 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-30 |
| Decision Date | 1986-07-03 |