The following data is part of a premarket notification filed by Axon Systems, Inc. with the FDA for Eclipse Neurological Workstation.
| Device ID | K050798 |
| 510k Number | K050798 |
| Device Name: | ECLIPSE NEUROLOGICAL WORKSTATION |
| 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 | 2005-03-29 |
| Decision Date | 2005-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169072053 | K050798 | 000 |
| 00643169553057 | K050798 | 000 |
| 00643169553071 | K050798 | 000 |
| 00643169553088 | K050798 | 000 |
| 00643169793873 | K050798 | 000 |
| 00643169020177 | K050798 | 000 |
| 00643169020191 | K050798 | 000 |
| 00643169071704 | K050798 | 000 |
| 00643169071711 | K050798 | 000 |
| 00643169071735 | K050798 | 000 |
| 00643169071742 | K050798 | 000 |
| 00643169071759 | K050798 | 000 |
| 00643169071773 | K050798 | 000 |
| 00643169071827 | K050798 | 000 |
| 00643169071865 | K050798 | 000 |
| 00643169071872 | K050798 | 000 |
| 00643169071933 | K050798 | 000 |
| 00643169071940 | K050798 | 000 |
| 00643169523548 | K050798 | 000 |