The following data is part of a premarket notification filed by Axon Systems, Inc. with the FDA for Epoch Xp Neurological Workstation; Epoch Xp Lite Neurological Workstation.
| Device ID | K022785 |
| 510k Number | K022785 |
| Device Name: | EPOCH XP NEUROLOGICAL WORKSTATION; EPOCH XP LITE NEUROLOGICAL WORKSTATION |
| Classification | Full-montage Standard Electroencephalograph |
| 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 | GWQ |
| Subsequent Product Code | GWE |
| Subsequent Product Code | GWF |
| Subsequent Product Code | GWJ |
| Subsequent Product Code | OLT |
| Subsequent Product Code | ORT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-22 |
| Decision Date | 2002-10-09 |
| Summary: | summary |