Stellate Systems
FDA Regulatory Profile
Stellate Systems appears in FDA public data with 1 recall, 7 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1080-2013, Class II) was initiated on April 6, 2009. Its most recent 510(k) clearance was granted on August 29, 2011.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 7
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1080-2013 | Class II | Harmonie software versions 5.1 uo to 6.2e : Harmonie-E Long Term Monitoring system (Models HSYS-REC | April 6, 2009 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K083577 | HARMONIE SYSTEM | August 29, 2011 |
| K013450 | NOTTA AMBULATORY RECORDER | January 14, 2002 |
| K010728 | HARMONE-SCHWARZER EEG SYSTEM | May 21, 2001 |
| K982351 | LUNA | July 29, 1998 |
| K955577 | ECLIPSE VERSION 3.0 | September 20, 1996 |
| K960273 | HARMONIE SENSA | April 4, 1996 |
| K912938 | RHYTHM | July 30, 1991 |