Company ยท US
General Devices
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 2002. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 5 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 |
| DSF | Recorder, Paper Chart | 1 |
| DSH | Recorder, Magnetic Tape, Medical | 1 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 1 |
| DXJ | Display, Cathode-Ray Tube, Medical | 1 |
| GYA | Tester, Electrode/Lead, Electroencephalograph | 1 |
| GZO | Device, Galvanic Skin Response Measurement | 1 |
| KRC | Tester, Electrode, Surface, Electrocardiographic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 18, 2002 | K013533 | EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000) General Devices | DRG |
| Nov 21, 2000 | K002089 | ROSETTA-LT/ROSETTA-RX General Devices | DRG |
| Dec 17, 1999 | K993202 | EIM-107 PREP-CHECK General Devices | GZO |
| Apr 14, 1995 | K940009 | GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300 General Devices | DRG |
| Nov 10, 1994 | K935839 | GEMSCOM SERIES 5000, General Devices | DRG |
| Sep 18, 1992 | K921929 | GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION) General Devices | DXH |
| Mar 4, 1992 | K914889 | GEMSCOM SERIES 3000 General Devices | DRG |
| Oct 9, 1991 | K912008 | TRU-VIEW MULTI-CHANNEL DISPLAY General Devices | DRT |
| Jan 19, 1990 | K896153 | MODIFIED DR-2C/PMC 100 General Devices | DSH |
| Sep 26, 1986 | K862596 | DR-2C (MODIFICATION) General Devices | DSF |
| Jan 22, 1985 | K844650 | DR-2C General Devices | DXJ |
| Jun 8, 1983 | K830877 | AP-CHECK General Devices | GYA |
| May 18, 1983 | K830876 | PREP-CHECK General Devices | KRC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||