21 C.F.R. § 884.2700 Intrauterine pressure monitor and accessories.
Title 21 - Food and Drugs
(a) 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. (b) Classification. Class II (performance standards).
Title 21: Food and Drugs
PART 884—OBSTETRICAL AND GYNECOLOGICAL DEVICES
Subpart C—Obstetrical and Gynecological Monitoring Devices
§ 884.2700 Intrauterine pressure monitor and accessories.
