# K981697: Cambridge Heart CH 2000 Cardiac Diagnostic System

- Pathway: 510(k) (Traditional)
- Applicant: Cambridge Heart, Inc.
- Decided: Oct 14, 1998 after 156 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K983102: Cardiac Diagnostic System Model CH 2000 (1999), 9 descendants of its own
- K012206: Alternanas Processing System, CH 2000 Cardiac Diagnostic System, Heartwave Alternans Processing System (2001), 6 descendants of its own
- K013565: Cardiac Diagnostic System, Model CH2000 (2001), 3 descendants of its own
- K022149: Cardiac Diagnostic System, Model CH2000 (2002), 2 descendants of its own
- K050225: Heartwave II Cardiac Diagnostic System (2005), 1 descendant of its own

## Indications for use
The CH 2000 is intended for the recording of electrocardiograms and vector cardiograms by a physician, or under the direction of a physician, at rest and during ECG stress testing. ECG stress testing is indicated for diagnostic and prognostic evaluation of patients with known or suspected cardiovascular disease. The correlation of the alternans results with a specific clinical diagnosis or prognosis, when the alternans are not visually apparent on the standard ECG has not been clinically established.

Source page: https://510kreport.com/device/K981697
Methodology: https://510kreport.com/methodology