(218 days)
Medine Blood Pressure Transducer is intended for direct measurement and monitoring of blood pressure. This disposable transducer is intended for single use only. Indications for use include: - . Direct arterial blood pressure monitoring - central and peripheral - Pulmonary artery monitoring (PA distal) . - Venous pressure monitoring (RA Proximal) ● - Left atrial monitoring when used with an air eliminator . - Cardiac catheterization .
Medline Blood Pressure Transducer
This document is a 510(k) premarket notification letter from the FDA regarding the Medline Blood Pressure Transducer. It does not contain information about acceptance criteria or a study that proves the device meets those criteria. Such information would typically be found in the 510(k) summary or the full submission, which are not provided here.
Therefore, I cannot answer the questions based on the provided text.
§ 870.2850 Extravascular blood pressure transducer.
(a)
Identification. An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.(b)
Classification. Class II (performance standards).