Cambridge Heart, Inc.
Medical device manufacturer in Tewksbury, MA.
17510(k) clearances
0PMA approvals
1recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K100362 | Cambridge Heart OemDQK · Special | 04/14/2010SE |
| K050225 | Heartwave II Cardiac Diagnostic SystemDQK · Special | 04/07/2005SE |
| K022152 | Heartwave Alternans Processing System, Model ApsDPS · Special | 07/16/2002SE |
| K022149 | Cardiac Diagnostic System, Model CH2000DPS · Special | 07/16/2002SE |
| K013565 | Cardiac Diagnostic System, Model CH2000DPS · Special | 11/21/2001SE |
| K013564 | Modification to Heartwave Alternans Processing System, Model ApsDPS · Special | 11/21/2001SE |
| K012206 | Alternanas Processing System, CH 2000 Cardiac Diagnostic System, Heartwave Alternans…DQK · Traditional | 10/12/2001SE |
| K011324 | Cambridge Heart Model CH 2000 Cardiac Diagnostic SystemDQK · Special | 05/23/2001SE |
| K010758 | Heartwave Alternans Processing System, ApsDPS · Special | 04/12/2001SE |
| K010756 | CH 2000 Cardiac Diagnostic SystemDQK · Special | 04/12/2001SE |
| K003492 | Analytic Spectral Method of Alternans Processing; CH 2000 Cardiac Diagnostic System…DQK · Traditional | 01/18/2001SE |
| K002230 | Cambridge Heart Micro-V Alternans Sensor, Model 20327-002DRX · Special | 08/18/2000SE |
| K001034 | Model Aps Alternans Processing SystemDPS · Special | 06/09/2000SE |
| K983102 | Cardiac Diagnostic System Model CH 2000DQK · Traditional | 04/12/1999SE |
| K981697 | Cambridge Heart CH 2000 Cardiac Diagnostic SystemDPS · Traditional | 10/14/1998SE |
| K962115 | Cambridge Heart Hi-Res ECG ElectrodeDRX · Traditional | 08/29/1996SE |
| K950018 | Cambridge Heart CH 2000 Stress Test SystemDPS · Traditional | 02/29/1996SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1776-2010 | The Alternans Sensor Kit Assembly is a sealed kit that contains the components necessary…Some kits contained a component with expiration date prior to the date of expiry on the outside of the kit.… | 04/29/2010Terminated |