(85 days)
The Sonicaid®One Fetal Heart Detector intended use is designed for early detection of fetal life and confirmation of continued life during pregnancy and labour.
Sonicaid® One Fetal Heart Detector
This document is a 510(k) clearance letter from the FDA for the Sonicaid® One Fetal Heart Detector. It primarily addresses the substantial equivalence of the device to a predicate device and regulatory compliance. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory approval rather than a detailed performance study.
§ 884.2740 Perinatal monitoring system and accessories.
(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).