CAREFONE(TM)HOME UTERINE ACTIVITY MONITOR SYSTEM
Device Facts
| Record ID | P910063 |
|---|---|
| Device Name | CAREFONE(TM)HOME UTERINE ACTIVITY MONITOR SYSTEM |
| Applicant | Matria Healthcare, Inc. |
| Product Code | LQK · Obstetrics/Gynecology |
| Decision Date | Sep 29, 1995 |
| Decision | APRL |
| Regulation | 21 CFR 884.2730 |
| Device Class | Class 2 |
Regulatory Classification
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.
Special Controls
*Classification.* Class II (special controls); guidance document (Class II Special Controls Guidance for Home Uterine Activity Monitors).
