(95 days)
The Cheetah NICOM system is a portable, non-invasive Cardiac Output monitoring device based on bio-Impedance Cardiography. The Cheetah NICOM system is intended to monitor and display a patient's Cardiac Output in units of [Ltr/Min].
The Cheetah NICOM system is a portable, non-invasive Cardiac Output monitoring device based on bio-Impedance Cardiography.
This document is a 510(k) clearance letter for the Cheetah NICOM System. It indicates that the device has been cleared by the FDA as substantially equivalent to legally marketed predicate devices. However, this document does not contain the acceptance criteria or the study that proves the device meets those criteria.
The letter itself is a regulatory approval, not a scientific study report. To find the information requested, you would typically need to refer to the original 510(k) submission documentation, which is not provided here.
Therefore, I cannot provide the requested information from the given text.
§ 870.1435 Single-function, preprogrammed diagnostic computer.
(a)
Identification. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.(b)
Classification. Class II (performance standards).