21 CFR 884.2700 — Transducer, Pressure, Intrauterine

Obstetrics/Gynecology (OB) · Part 884 Subpart C—Obstetrical and Gynecological Monitoring Devices · § 884.2700

Identification

An intrauterine pressure monitor is a device designed to detect and measure intrauterine and amniotic fluid pressure with a catheter placed transcervically into the uterine cavity. The device is used to monitor intensity, duration, and frequency of uterine contractions during labor. This generic type of device may include the following accessories: signal analysis and display equipment, patient and equipment supports, and component parts.

Classification Rationale

Class II (performance standards).

Product Codes