Company ยท CA
Stellate Systems
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2011. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GWQ | Full-Montage Standard Electroencephalograph | 3 |
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | 2 |
| OLV | Standard Polysomnograph With Electroencephalograph | 2 |
| GWS | Analyzer, Spectrum, Electroencephalogram Signal | 1 |
| OMB | Automatic Event Detection Software For Full-Montage Electroencephalograph | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 29, 2011 | K083577 | HARMONIE SYSTEM Stellate Systems, CA | GWQ |
| Jan 14, 2002 | K013450 | NOTTA AMBULATORY RECORDER Stellate Systems, CA | OLV |
| May 21, 2001 | K010728 | HARMONE-SCHWARZER EEG SYSTEM Stellate Systems, CA | OLV |
| Jul 29, 1998 | K982351 | LUNA Stellate Systems, CA | OLT |
| Sep 20, 1996 | K955577 | ECLIPSE VERSION 3.0 Stellate Systems, CA | OLT |
| Apr 4, 1996 | K960273 | HARMONIE SENSA Stellate Systems, CA | OMB |
| Jul 30, 1991 | K912938 | RHYTHM Stellate Systems, CA | GWS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 22, 2013 | Stellate Systems 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 S Terminated |
GWQ | K010728 K083577 |
| Jan 11, 2012 | Stellate Systems 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 Terminated |
GWQ | None listed |