The following data is part of a premarket notification filed by Axon Systems, Inc. with the FDA for Unique Ambulatory Eeg.
| Device ID | K010697 |
| 510k Number | K010697 |
| Device Name: | UNIQUE AMBULATORY EEG |
| 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 |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-08 |
| Decision Date | 2001-06-06 |