The following data is part of a premarket notification filed by Stellate Systems with the FDA for Eclipse Version 3.0.
| Device ID | K955577 |
| 510k Number | K955577 |
| Device Name: | ECLIPSE VERSION 3.0 |
| Classification | Non-normalizing Quantitative Electroencephalograph Software |
| Applicant | STELLATE SYSTEMS 345 VICTORIA AVE., SUITE 505 WESTMOUNT, QUEBEC, Canada, H32 2n2, CA |
| Contact | George Papagiannis |
| Correspondent | George Papagiannis STELLATE SYSTEMS 345 VICTORIA AVE., SUITE 505 WESTMOUNT, QUEBEC, Canada, H32 2n2, CA |
| Product Code | OLT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-08 |
| Decision Date | 1996-09-20 |