Cambridge Heart, Inc. - FDA 510(k) Cleared Devices
Recent clearances: CAMBRIDGE HEART OEM, HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM, CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000
17
Total
17
Cleared
0
Denied
FDA 510(k) Regulatory Record - Cambridge Heart, Inc. Cardiovascular ✕
17 devices
Cleared
Apr 14, 2010
CAMBRIDGE HEART OEM
Cardiovascular
61d
Cleared
Apr 07, 2005
HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM
Cardiovascular
65d
Cleared
Jul 16, 2002
CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000
Cardiovascular
14d
Cleared
Jul 16, 2002
HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
Cardiovascular
14d
Cleared
Nov 21, 2001
MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
Cardiovascular
26d
Cleared
Nov 21, 2001
CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000
Cardiovascular
26d
Cleared
Oct 12, 2001
ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE...
Cardiovascular
91d
Cleared
May 23, 2001
CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM
Cardiovascular
22d
Cleared
Apr 12, 2001
CH 2000 CARDIAC DIAGNOSTIC SYSTEM
Cardiovascular
30d
Cleared
Apr 12, 2001
HEARTWAVE ALTERNANS PROCESSING SYSTEM, APS
Cardiovascular
30d
Cleared
Jan 18, 2001
ANALYTIC SPECTRAL METHOD OF ALTERNANS PROCESSING
Cardiovascular
66d
Cleared
Aug 18, 2000
CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002
Cardiovascular
25d