General Devices
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 13
- Inspections
- 4
- Compliance Actions
- 1
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K013533 | EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000) | January 18, 2002 |
| K002089 | ROSETTA-LT/ROSETTA-RX | November 21, 2000 |
| K993202 | EIM-107 PREP-CHECK | December 17, 1999 |
| K940009 | GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300 | April 14, 1995 |
| K935839 | GEMSCOM SERIES 5000, | November 10, 1994 |
| K921929 | GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION) | September 18, 1992 |
| K914889 | GEMSCOM SERIES 3000 | March 4, 1992 |
| K912008 | TRU-VIEW MULTI-CHANNEL DISPLAY | October 9, 1991 |
| K896153 | MODIFIED DR-2C/PMC 100 | January 19, 1990 |
| K862596 | DR-2C (MODIFICATION) | September 26, 1986 |
| K844650 | DR-2C | January 22, 1985 |
| K830877 | AP-CHECK | June 8, 1983 |
| K830876 | PREP-CHECK | May 18, 1983 |