MOH · Monitor, Heart Rate, Fetal, Non-Stress Test (Home Use)
Obstetrics/Gynecology · 21 CFR 884.2730 · Class 2
Overview
| Product Code | MOH |
|---|---|
| Device Name | Monitor, Heart Rate, Fetal, Non-Stress Test (Home Use) |
| Regulation | 21 CFR 884.2730 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
Identification
A home uterine activity monitor (HUAM) is an electronic system for at home antepartum measurement of uterine contractions. The HUAM system comprises a tocotransducer and an at-home recorder. This device is intended for use in women with a previous preterm delivery to aid in the detection of preterm labor.
Classification Rationale
Class II (special controls); guidance document (Class II Special Controls Guidance for Home Uterine Activity Monitors).
Special Controls
*Classification.* Class II (special controls); guidance document (Class II Special Controls Guidance for Home Uterine Activity Monitors).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
