510(k) K010728 ยท OLV Standard Polysomnograph With Electroencephalograph
HARMONE-SCHWARZER EEG SYSTEM
| Applicant | Stellate Systems, Westmount, Quebec, CA |
| Decision | Substantially Equivalent, May 21, 2001 |
| Received | Mar 12, 2001 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K010728
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.