21 CFR 884.2720 — Monitor, Uterine Contraction, External (For Use In Clinic)
Obstetrics/Gynecology (OB) · Part 884 Subpart C—Obstetrical and Gynecological Monitoring Devices · § 884.2720
Identification
An external uterine contraction monitor (i.e., the tokodynamometer) is a device used to monitor the progress of labor. It measures the duration, frequency, and relative pressure of uterine contractions with a transducer strapped to the maternal abdomen. This generic type of device may include an external pressure transducer, support straps, and other patient and equipment supports.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HFM | Monitor, Uterine Contraction, External (For Use In Clinic) | 2 | 24 | 3rd Party |
| OSP | Uterine Electromyographic Monitor | 2 | 10 |
