Gould, Inc.
Medical device manufacturer in Valley View, OH.
31510(k) clearances
0PMA approvals
0recalls
Device types
- DRS Transducer, Blood-Pressure, Extravascular 6
- DXG Computer, Diagnostic, Pre-Programmed… 4
- KRB Probe, Thermodilution 4
- DRT Monitor, Cardiac (Incl. Cardiotachometer &… 3
- DYG Catheter, Flow Directed 2
- DQO Catheter, Intravascular, Diagnostic 2
- DXJ Display, Cathode-Ray Tube, Medical 1
- DSK Computer, Blood-Pressure 1
- KRA Catheter, Continuous Flush 1
- DQK Computer, Diagnostic, Programmable 1
- DYB Introducer, Catheter 1
- DXN System, Measurement, Blood-Pressure… 1
- CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase 1
- DXO Transducer, Pressure, Catheter Tip 1
- BZG Spirometer, Diagnostic 1
- DRR Amplifier And Signal Conditioner… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K911935 | Cardiac Electrophysical Lead Selector, ModifiedDRR · Traditional | 07/22/1991SE |
| K861092 | Model SP1465 Cardiac Output ComputerDXG · Traditional | 08/18/1986SE |
| K860805 | Pressure Monitor Cath Models SP5325,SP5327,SP5337DQO · Traditional | 05/08/1986SE |
| K855145 | Model:Ta-Rose Resonant Overshoot EliminatorDRS · Traditional | 02/26/1986SE |
| K854403 | Model 2120 SpiroscreenBZG · Traditional | 01/14/1986SE |
| K851486 | Gould Disposable Transducer & Accessories-DtxDRS · Traditional | 10/17/1985SE |
| K850114 | C/Pes 9201, ECG Stress Testing SysDRT · Traditional | 02/22/1985SE |
| K850113 | C/Pes 9103, ECG Stress Testing SystemDRT · Traditional | 02/08/1985SE |
| K843555 | Cardiac Computer SP1445DXG · Traditional | 02/01/1985SE |
| K843969 | Model P23XL Physiological Pressure TransducerDXO · Traditional | 01/23/1985SE |
| K843970 | Model IM1074 End-Tidal CO2 ModuleCCK · Traditional | 10/24/1984SE |
| K840909 | Automated Non-Invasive Pressure ModuleDXN · Traditional | 06/15/1984SE |
| K840992 | Thermodilution CatheterKRB · Traditional | 05/23/1984SE |
| K840824 | Heparin Coated Thermodilution CathetersKRB · Traditional | 05/23/1984SE |
| K830885 | Gould Model IM3000-IM3100 Battery PowerDRT · Traditional | 06/22/1983SE |
| K830523 | Catheter Connection W/Integral InjectateDQO · Traditional | 03/16/1983SE |
| K823262 | Model SP5800 #8 French Intro. KitDYB · Traditional | 01/18/1983SE |
| K822507 | Disposable Transducer & AccessoriesDRS · Traditional | 09/14/1982SE |
| K821450 | Pressure Tubing-Adult & PediatricDRS · Traditional | 05/25/1982SE |
| K821235 | Heparin Coated Thermodilution CatheterDYG · Traditional | 05/18/1982SE |
| K811537 | Model SP 5507 5-LUMEN Thermodilution CatKRB · Traditional | 06/18/1981SE |
| K811538 | Models Ta 1017 & 1017T Gritiflo DisposDRS · Traditional | 06/12/1981SE |
| K810731 | Model IM1000 Integrated MonitorDQK · Traditional | 03/27/1981SE |
| K810730 | Model SP5107 Thermodilution CatheterKRB · Traditional | 03/27/1981SE |
| K802476 | Cardiacindex Computer Model SP 1435DXG · Traditional | 11/19/1980SE |
| K791844 | Critiflo & Critiflo DomeKRA · Traditional | 10/02/1979SE |
| K780798 | Gould-Statham SP1405 Pressure MonitorDSK · Traditional | 06/13/1978SE |
| K780797 | Transducer, Pressure, Option, H-P, P23IDDRS · Traditional | 06/13/1978SE |
| K780425 | Biophysical Monitoring SystemDXJ · Traditional | 04/28/1978SE |
| K760533 | Catheter, Flow Directed Thermal DilutionDYG · Traditional | 09/09/1976SE |
| K760532 | Computer, Cardiac Output (#SP1425)DXG · Traditional | 09/09/1976SE |