FDA 510(k) Applications Submitted by CAMBRIDGE HEART, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K050225 |
02/01/2005 |
HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM |
CAMBRIDGE HEART, INC. |
| K100362 |
02/12/2010 |
CAMBRIDGE HEART OEM |
CAMBRIDGE HEART, INC. |
| K010756 |
03/13/2001 |
CH 2000 CARDIAC DIAGNOSTIC SYSTEM |
CAMBRIDGE HEART, INC. |
| K010758 |
03/13/2001 |
HEARTWAVE ALTERNANS PROCESSING SYSTEM, APS |
CAMBRIDGE HEART, INC. |
| K001034 |
03/31/2000 |
MODEL APS ALTERNANS PROCESSING SYSTEM |
CAMBRIDGE HEART, INC. |
| K011324 |
05/01/2001 |
CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM |
CAMBRIDGE HEART, INC. |
| K022149 |
07/02/2002 |
CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000 |
CAMBRIDGE HEART, INC. |
| K022152 |
07/02/2002 |
HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS |
CAMBRIDGE HEART, INC. |
| K012206 |
07/13/2001 |
ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM |
CAMBRIDGE HEART, INC. |
| K002230 |
07/24/2000 |
CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002 |
CAMBRIDGE HEART, INC. |
| K013564 |
10/26/2001 |
MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS |
CAMBRIDGE HEART, INC. |
| K013565 |
10/26/2001 |
CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000 |
CAMBRIDGE HEART, INC. |
| K003492 |
11/13/2000 |
ANALYTIC SPECTRAL METHOD OF ALTERNANS PROCESSING; CH 2000 CARDIAC DIAGNOSTIC SYSTEM; HEARTWAVE ALTERNANS PROCESSING SYS |
CAMBRIDGE HEART, INC. |
| K981697 |
05/11/1998 |
CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEM |
CAMBRIDGE HEART, INC. |
| K983102 |
09/03/1998 |
CARDIAC DIAGNOSTIC SYSTEM MODEL CH 2000 |
CAMBRIDGE HEART, INC. |
| K950018 |
01/03/1995 |
CAMBRIDGE HEART CH 2000 STRESS TEST SYSTEM |
CAMBRIDGE HEART, INC. |
| K962115 |
05/31/1996 |
CAMBRIDGE HEART HI-RES ECG ELECTRODE |
CAMBRIDGE HEART, INC. |
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