The following data is part of a premarket notification filed by Axon Systems, Inc. with the FDA for Ss102 Dual Channel Sep Stimulator.
| Device ID | K955257 |
| 510k Number | K955257 |
| Device Name: | SS102 DUAL CHANNEL SEP STIMULATOR |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | AXON SYSTEMS, INC. 400-2200 OSER AVE. Hauppauge, NY 11788 |
| Contact | Howard Bailin |
| Correspondent | Howard Bailin AXON SYSTEMS, INC. 400-2200 OSER AVE. Hauppauge, NY 11788 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-07 |
| Decision Date | 1996-02-02 |