# General Devices

- Location (FDA's records): Ridgefield, NJ
- FDA decisions: 13 (1983–2002): 13 510(k) clearances
- Product codes: DRG (5), GZO (1), KRC (1), DXH (1), DSH (1), DXJ (1), DRT (1), GYA (1), DSF (1)
- Predicates its devices cite: 2 (2 its own); citations of its devices by later devices: 3 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Molex, Inc.: 1 (https://510kreport.com/company/molex)

## Its most-cited devices
- K002089: Rosetta-LT/Rosetta-RX (2000), cited by 2
- K896153: Modified DR-2C/PMC 100 (1990), cited by 1

## Recent decisions
- K013533: Ems Telemedicine Option (for Gems Series 4000) (Jan 18, 2002)
- K002089: Rosetta-LT/Rosetta-RX (Nov 21, 2000)
- K993202: Eim-107 Prep-Check (Dec 17, 1999)
- K940009: Gemscom Series 6000, Models 6100, 6200 & 6300 (Apr 14, 1995)
- K935839: Gemscom Series 5000, (Nov 10, 1994)
- K921929: Gemscom Series 300 12-Lead Ecg (12-Lead Option) (Sep 18, 1992)
- K914889: Gemscom Series 3000 (Mar 4, 1992)
- K912008: Tru-View Multi-Channel Display (Oct 9, 1991)

Source page: https://510kreport.com/company/general-devices