The following data is part of a premarket notification filed by Stellate Systems with the FDA for Harmonie Sensa.
| Device ID | K960273 |
| 510k Number | K960273 |
| Device Name: | HARMONIE SENSA |
| Classification | Automatic Event Detection Software For Full-montage Electroencephalograph |
| Applicant | STELLATE SYSTEMS 345 VICTORIA AVE., SUITE 300 Westmount, Quebec, CA H3z 2n2 |
| Contact | George Papagiannis |
| Correspondent | George Papagiannis STELLATE SYSTEMS 345 VICTORIA AVE., SUITE 300 Westmount, Quebec, CA H3z 2n2 |
| Product Code | OMB |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-19 |
| Decision Date | 1996-04-04 |