General Devices
Ridgefield, NJ, US
General Devices appears in FDA device records in Ridgefield, NJ. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for General Devices between 1983 and 2002. The busiest year on record is 1983, with 2. The most recent is 2002, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 2 |
| 1985 | 1 |
| 1986 | 1 |
| 1990 | 1 |
| 1991 | 1 |
| 1992 | 2 |
| 1994 | 1 |
| 1995 | 1 |
| 1999 | 1 |
| 2000 | 1 |
| 2002 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K013533 | EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000) | DRG | Substantially Equivalent | |
| K002089 | ROSETTA-LT/ROSETTA-RX | DRG | Substantially Equivalent | |
| K993202 | EIM-107 PREP-CHECK | GZO | Substantially Equivalent | |
| K940009 | GEMSCOM SERIES 6000, MODELS 6100, 6200 & 6300 | DRG | Substantially Equivalent | |
| K935839 | GEMSCOM SERIES 5000, | DRG | Substantially Equivalent | |
| K921929 | GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION) | DXH | Substantially Equivalent | |
| K914889 | GEMSCOM SERIES 3000 | DRG | Substantially Equivalent | |
| K912008 | TRU-VIEW MULTI-CHANNEL DISPLAY | DRT | Substantially Equivalent | |
| K896153 | MODIFIED DR-2C/PMC 100 | DSH | Substantially Equivalent | |
| K862596 | DR-2C (MODIFICATION) | DSF | Substantially Equivalent | |
| K844650 | DR-2C | DXJ | Substantially Equivalent | |
| K830877 | AP-CHECK | GYA | Substantially Equivalent | |
| K830876 | PREP-CHECK | KRC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GZODevice, Galvanic Skin Response Measurement
- DXJDisplay, Cathode-Ray Tube, Medical
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- DSHRecorder, Magnetic Tape, Medical
- DSFRecorder, Paper Chart
- KRCTester, Electrode, Surface, Electrocardiographic
- GYATester, Electrode/Lead, Electroencephalograph
- DXHTransmitters And Receivers, Electrocardiograph, Telephone
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain