§884.2700. Intrauterine pressure monitor and accessories.
21 C.F.R. § 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. Class II (performance standards).
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.
Source
Source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.