DR-2C (Modification)
FDA 510(k) K862596 · General Devices
510(k) numberK862596
Submission
- Device name
- DR-2C (Modification)
- Applicant
- General Devices
Bergenfield, NJ, US - Received
- June 27, 1986
- Decision date
- September 26, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DSF – Recorder, Paper Chart
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.2810
- Specialty
- Cardiovascular
Other 510(k)s with product code DSF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K910871 | Edentec Digital Charter Model 3710DSF · Traditional | Edentec Corp. | 08/29/1991SE |
| K912929 | Dash IVDSF · Traditional | Astro-Med, Inc. | 08/13/1991SE |
| K905856 | Model 556 MonitorDSF · Traditional | Ge Medical Systems Information Technologies | 01/11/1991SE |
| K902586 | Gri Lasergraph(Tm) ECG PaperDSF · Traditional | Gri Medical Products, Inc. | 06/22/1990SE |
| K902230 | Colorado Color Imaging RecorderDSF · Traditional | Honeywell, Inc. | 06/19/1990SE |
| K901385 | Gabriel Medical CLS Thermal RecorderDSF · Traditional | Gabriel Medical, Inc. | 05/09/1990SE |
| K895111 | Type 9541 Recorder, Paper ChartDSF · Traditional | S & W Medico Teknik | 01/26/1990SE |
| K894922 | WR3500 and WR3600 Series RecordersDSF · Traditional | Western Graphtec | 01/26/1990SE |
| K894736 | MT96000 Paper Chart RecorderDSF · Traditional | Astro-Med, Inc. | 12/13/1989SE |
| K894607 | PAQ10 Paper Chart RecorderDSF · Traditional | Protocol Systems, Inc. | 10/26/1989SE |
More from Protocol Systems, Inc.
| 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 |
| K844650 | DR-2CDXJ · Traditional | 01/22/1985SE |
Questions and answers
When was DR-2C (Modification) cleared by the FDA?
DR-2C (Modification) (K862596) received a 510(k) decision of Substantially Equivalent on September 26, 1986, 91 days after the submission was received.
What is the product code of K862596?
The FDA product code is DSF – Recorder, Paper Chart, a Class I (low risk) device regulated under 21 CFR 870.2810.