The following data is part of a premarket notification filed by Stellate Systems with the FDA for Harmonie System.
| Device ID | K083577 |
| 510k Number | K083577 |
| Device Name: | HARMONIE SYSTEM |
| Classification | Full-montage Standard Electroencephalograph |
| Applicant | STELLATE SYSTEMS 376 VICTORIA AVENUE, SUITE 200 Montreal, Quebec, CA H3z 1c3 |
| Contact | Goldy Singh |
| Correspondent | Goldy Singh STELLATE SYSTEMS 376 VICTORIA AVENUE, SUITE 200 Montreal, Quebec, CA H3z 1c3 |
| Product Code | GWQ |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-03 |
| Decision Date | 2011-08-29 |
| Summary: | summary |