Stellate Systems
Westmount, Quebec, CA
Stellate Systems appears in FDA device records in Westmount, Quebec, CA. FDA records list 7 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Stellate Systems between 1991 and 2011. The busiest year on record is 1996, with 2. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 1 |
| 1996 | 2 |
| 1998 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K083577 | HARMONIE SYSTEM | GWQ | Substantially Equivalent | |
| K013450 | NOTTA AMBULATORY RECORDER | OLV | Substantially Equivalent | |
| K010728 | HARMONE-SCHWARZER EEG SYSTEM | OLV | Substantially Equivalent | |
| K982351 | LUNA | OLT | Substantially Equivalent | |
| K955577 | ECLIPSE VERSION 3.0 | OLT | Substantially Equivalent | |
| K960273 | HARMONIE SENSA | OMB | Substantially Equivalent | |
| K912938 | RHYTHM | GWS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0487-2012 | Harmonie software in use with: Harmonie-E Long Term Monitoring System (Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC-LT2; HSYS-REC-EAMP) Harmonie-S Sleep System (Model HSYS-REC-DUO) VITA/ICU Neurological Monitoring System (Model HSYS-REC-DUO-PPC) Harmonie{-S}{-E} Readers (Models HSYS-RDR-D, HSYS-RDR-T). Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations. | The following implied or stated indications in Stellate labeling with Harmoniae software have not yet been cleared by the Food and Drug Administration (FDA) for sale in the United States of America. | Terminated | ||
| Z-1080-2013 | Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring system (Models HSYS-REC-WD, HSYS-REC-WT; HSYS-REC0LT2; HSYS-REC-EAMP) Product in use with Harmonie-E Long Term Monitoring System : ICTA-S & ICTA-D Seizure Detector, Slow wave Seizure Detector Harmonie-S Sleep System: Rapid Eye Movement Detector, Spindle Detector, Heart Rate Processor, Periodic Leg Movement Detector and Oximetry/Pulse rate Threshold Notification VITA/ICU Neurological Monitoring System: Burst Suppression Detector, Cerebral Function Monitor Trend, Visual and Auditory Notifications on all trends graphs in PolyTrends Harmonie {-s}{-E} Readers , | The firm is initiating this recall because the implied or stated indications in their labeling associated with Harmonie software have not yet been cleared by the FDA for sale in the USA. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain