# Cambridge Heart, Inc.

- Location (FDA's records): South West Ranches, FL
- FDA decisions: 17 (1996–2010): 17 510(k) clearances
- Product codes: DPS (8), DQK (7), DRX (2)
- Predicates its devices cite: 18 (12 its own); citations of its devices by later devices: 17 (12 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Zymed Medical Instrumentation: 1 (https://510kreport.com/company/zymed-medical-instrumentation)
- Burdick Corp.: 1 (https://510kreport.com/company/burdick)
- Electronics For Medicine, Inc.: 1 (https://510kreport.com/company/electronics-for-medicine)
- Quinton, Inc.: 1 (https://510kreport.com/company/quinton)
- 3M Company: 1 (https://510kreport.com/company/3m)
- Waltham Div. Hewlett Packard: 1 (https://510kreport.com/company/waltham-div-hewlett-packard)

## Firms that cite its devices most
- Harbinger Medical, Inc.: 5 (https://510kreport.com/company/harbinger-medical)

## Its most-cited devices
- K983102: Cardiac Diagnostic System Model CH 2000 (1999), cited by 2
- K010756: CH 2000 Cardiac Diagnostic System (2001), cited by 2
- K010758: Heartwave Alternans Processing System, Aps (2001), cited by 2
- K012206: Alternanas Processing System, CH 2000 Cardiac Diagnostic System, Heartwave Alternans Processing System (2001), cited by 2
- K050225: Heartwave II Cardiac Diagnostic System (2005), cited by 1
- K022149: Cardiac Diagnostic System, Model CH2000 (2002), cited by 1

## Recent decisions
- K100362: Cambridge Heart Oem (Apr 14, 2010)
- K050225: Heartwave II Cardiac Diagnostic System (Apr 7, 2005)
- K022152: Heartwave Alternans Processing System, Model Aps (Jul 16, 2002)
- K022149: Cardiac Diagnostic System, Model CH2000 (Jul 16, 2002)
- K013565: Cardiac Diagnostic System, Model CH2000 (Nov 21, 2001)
- K013564: Modification to Heartwave Alternans Processing System, Model Aps (Nov 21, 2001)
- K012206: Alternanas Processing System, CH 2000 Cardiac Diagnostic System, Heartwave Alternans Processing System (Oct 12, 2001)
- K011324: Cambridge Heart Model CH 2000 Cardiac Diagnostic System (May 23, 2001)

Source page: https://510kreport.com/company/cambridge-heart