TERM GUARD II DEVICE
Device Facts
| Record ID | K893770 |
|---|---|
| Device Name | TERM GUARD II DEVICE |
| Applicant | Tokos Medical Corp. |
| Product Code | HFM · Obstetrics/Gynecology |
| Decision Date | Nov 3, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.2720 |
| Device Class | Class 2 |
Regulatory Classification
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.
