(25 days)
Monitoring of blood flow in veins and arteries to assist in the detection of vascular disease and detection of early fetal heartbeat Instrument used in doctor's office, clinic or hospital, by use for on the order of a physician.
The device is for non-invasive use only. The device is not to be used on or near non-intact skin. The device is not to be used on or near the eyes. The device is to be used by or on order of a physician.
Not Found
This document is an FDA 510(k) clearance letter for the Nicolet Vascular Inc. CareDop II. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
Therefore, I cannot extract the requested information regarding acceptance criteria and device performance studies from this document.
§ 892.1540 Nonfetal ultrasonic monitor.
(a)
Identification. A nonfetal ultrasonic monitor is a device that projects a continuous high-frequency sound wave into body tissue other than a fetus to determine frequency changes (doppler shift) in the reflected wave and is intended for use in the investigation of nonfetal blood flow and other nonfetal body tissues in motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.