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Cambridge Heart, Inc.

FDA 510(k) & PMA Approved Devices — 17 products

Total Devices17
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K100362 CAMBRIDGE HEART OEMDQK2010-04-14 View
510(k) K050225 HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEMDQK2005-04-07 View
510(k) K022149 CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000DPS2002-07-16 View
510(k) K022152 HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APSDPS2002-07-16 View
510(k) K013565 CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000DPS2001-11-21 View
510(k) K013564 MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APSDPS2001-11-21 View
510(k) K012206 ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEMDQK2001-10-12 View
510(k) K011324 CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEMDQK2001-05-23 View
510(k) K010758 HEARTWAVE ALTERNANS PROCESSING SYSTEM, APSDPS2001-04-12 View
510(k) K010756 CH 2000 CARDIAC DIAGNOSTIC SYSTEMDQK2001-04-12 View
510(k) K003492 ANALYTIC SPECTRAL METHOD OF ALTERNANS PROCESSING; CH 2000 CARDIAC DIAGNOSTIC SYSTEM; HEARTWAVE ALTERNANS PROCESSING SYSDQK2001-01-18 View
510(k) K002230 CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002DRX2000-08-18 View
510(k) K001034 MODEL APS ALTERNANS PROCESSING SYSTEMDPS2000-06-09 View
510(k) K983102 CARDIAC DIAGNOSTIC SYSTEM MODEL CH 2000DQK1999-04-12 View
510(k) K981697 CAMBRIDGE HEART CH 2000 CARDIAC DIAGNOSTIC SYSTEMDPS1998-10-14 View
510(k) K962115 CAMBRIDGE HEART HI-RES ECG ELECTRODEDRX1996-08-29 View
510(k) K950018 CAMBRIDGE HEART CH 2000 STRESS TEST SYSTEMDPS1996-02-29 View
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