Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Cambridge Heart, Inc. with 17 510(k) clearances. The most recent is a 510(k) clearance dated Apr 14, 2010: CAMBRIDGE HEART OEM.
| Apr 14, 2010 | CAMBRIDGE HEART OEMK100362 · DQK | 510(k) clearances |
| Apr 7, 2005 | HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEMK050225 · DQK | 510(k) clearances |
| Jul 16, 2002 | HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APSK022152 · DPS | 510(k) clearances |
| Jul 16, 2002 | CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000K022149 · DPS | 510(k) clearances |
| Nov 21, 2001 | MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APSK013564 · DPS | 510(k) clearances |
| Nov 21, 2001 | CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000K013565 · DPS | 510(k) clearances |
| Oct 12, 2001 | ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEMK012206 · DQK | 510(k) clearances |
| May 23, 2001 | CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEMK011324 · DQK | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
