Stellate Systems
Medical device manufacturer in Montreal, Quebec, CA.
7510(k) clearances
0PMA approvals
2recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K083577 | Harmonie SystemGWQ · Abbreviated | 08/29/2011SE |
| K013450 | Notta Ambulatory RecorderOLV · Abbreviated | 01/14/2002SE |
| K010728 | Harmone-Schwarzer EEG SystemOLV · Abbreviated | 05/21/2001SE |
| K982351 | LunaOLT · Special | 07/29/1998SE |
| K955577 | Eclipse Version 3.0OLT · Traditional | 09/20/1996SE |
| K960273 | Harmonie SensaOMB · Traditional | 04/04/1996SE |
| K912938 | RhythmGWS · Traditional | 07/30/1991SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0487-2012 | Harmonie software in use with: Harmonie-E Long Term Monitoring System (Models…The following implied or stated indications in Stellate labeling with Harmoniae software have not yet been… | 04/16/2009Terminated |
| Z-1080-2013 Class II | Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring system…The firm is initiating this recall because the implied or stated indications in their labeling associated… | 04/06/2009Terminated |