PDS, MODEL NST 40 FETAL MONITOR, RECORDER & TRANS.
Device Facts
| Record ID | K873150 |
|---|---|
| Device Name | PDS, MODEL NST 40 FETAL MONITOR, RECORDER & TRANS. |
| Applicant | Pediatric Diagnostic Service |
| Product Code | HFM · Obstetrics/Gynecology |
| Decision Date | Mar 11, 1988 |
| 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.
