The following data is part of a premarket notification filed by Axon Systems, Inc. with the FDA for Software & Hardware Addition To Sentinel-4 Eeg.
| Device ID | K900482 |
| 510k Number | K900482 |
| Device Name: | SOFTWARE & HARDWARE ADDITION TO SENTINEL-4 EEG |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | AXON SYSTEMS, INC. 40-2 OSER AVE. Hauppauge, NY 11788 |
| Contact | Howard Bailin |
| Correspondent | Howard Bailin AXON SYSTEMS, INC. 40-2 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 | 1990-02-01 |
| Decision Date | 1990-06-20 |