(156 days)
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.
Model CH 2000 Cardiac Diagnostic System
This document is a 510(k) clearance letter from the FDA for the Cambridge Heart, Inc. CH 2000 Cardiac Diagnostic System. It does not contain the detailed acceptance criteria and study information typically found in a clinical study report or product submission.
Therefore, I cannot extract the requested information from the provided text. The letter only confirms that the device is substantially equivalent to legally marketed predicate devices. To answer your questions, I would need a different type of document, such as the 510(k) submission itself or a clinical study report for the CH 2000 Cardiac Diagnostic System.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).