General Devices
Medical device manufacturer in Ridgefield, NJ.
13510(k) clearances
0PMA approvals
0recalls
Device types
- DRG Transmitters And Receivers, Physiological… 5
- KRC Tester, Electrode, Surface, Electrocardiogra… 1
- GYA Tester, Electrode/Lead, Electroencephalograph 1
- DXJ Display, Cathode-Ray Tube, Medical 1
- DSF Recorder, Paper Chart 1
- DSH Recorder, Magnetic Tape, Medical 1
- DRT Monitor, Cardiac (Incl. Cardiotachometer &… 1
- DXH Transmitters And Receivers, Electrocardiogra… 1
- GZO Device, Galvanic Skin Response Measurement 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K013533 | EMS Telemedicine Option (for Gems Series 4000)DRG · Traditional | 01/18/2002SE |
| K002089 | Rosetta-Lt/Rosetta-RxDRG · Traditional | 11/21/2000SE |
| K993202 | EIM-107 Prep-CheckGZO · Traditional | 12/17/1999SE |
| K940009 | Gemscom Series 6000, Models 6100, 6200 & 6300DRG · Traditional | 04/14/1995SE |
| K935839 | Gemscom Series 5000,DRG · Traditional | 11/10/1994SE |
| K921929 | Gemscom Series 300 12-LEAD ECG (12-LEAD Option)DXH · Traditional | 09/18/1992SE |
| K914889 | Gemscom Series 3000DRG · Traditional | 03/04/1992SE |
| K912008 | Tru-View Multi-Channel DisplayDRT · Traditional | 10/09/1991SE |
| K896153 | Modified DR-2C/PMC 100DSH · Traditional | 01/19/1990SE |
| K862596 | DR-2C (Modification)DSF · Traditional | 09/26/1986SE |
| K844650 | DR-2CDXJ · Traditional | 01/22/1985SE |
| K830877 | Ap-CheckGYA · Traditional | 06/08/1983SE |
| K830876 | Prep-CheckKRC · Traditional | 05/18/1983SE |