The following data is part of a premarket notification filed by Axon Systems, Inc. with the FDA for Sentinel 4 Eeg Analyzer.
| Device ID | K863193 |
| 510k Number | K863193 |
| Device Name: | SENTINEL 4 EEG ANALYZER |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | AXON SYSTEMS, INC. 62M SOUTH SECOND ST. Deer Park, NY 11729 |
| Contact | Howard Bailin |
| Correspondent | Howard Bailin AXON SYSTEMS, INC. 62M SOUTH SECOND ST. Deer Park, NY 11729 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-19 |
| Decision Date | 1986-12-02 |