(336 days)
The ANS2000 is an ECG Monitor and Respiration Pacer that measures heart rate and provides a respiration timer for the purpose of measuring heart rate variations in response to respiration. The measuring board is used in studies of patients in which it is important to know the interval between heartbeats and also to have analysis with the patient's breathing.
The ANS2000 is an ECG Monitor and Respiration Pacer.
The provided text is a 510(k) premarket notification letter from the FDA to D.E. Hokanson, Incorporated, regarding their ANS2000 ECG Monitor and Respiration Pacer. This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is solely a regulatory letter indicating that the device has been found substantially equivalent to a predicate device for its stated indications for use.
To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a clinical study report.
§ 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).