Analyzer, Data, Obstetric
Basic Information
- Device Name
- Analyzer, Data, Obstetric
- Trade Name
- STAN S31 SYSTEM
- PMA Number
- P020001
- Supplement Number
- S007
- Device Class
- FDA Class 3
- Product Code
- HEO
- Generic Name
- Analyzer, data, obstetric
- Regulation Number
- 884.2050
- Medical Specialty
- Obstetrics/Gynecology
- Advisory Committee
- Obstetrics/Gynecology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- February 1, 2010
- Date Received
- July 23, 2009
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR VARIOUS HARDWARE, SOFTWARE, AND LABELING UPGRADES INCLUDINGINTEGRATION OF MATERNAL NON-INVASIVE BLOOD PRESSURE AND OXYGEN SATURATION MONITORING ANDALARMS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STAN S31 AND ISINDICATED FOR:MONITORING OF FETUS AND MOTHER THROUGHOUT LABOR AND DELIVERY. THE FOLLOWING PARAMETERSCAN BE MONITORED WITH STAN S31: 1) FETAL HEART RATE; 2) FETAL ECG WAVEFORM; 3) UTERINE ACTIVITY; 4) MATERNAL NON-INVASIVE BLOOD PRESSURE; 5) MATERNAL SPO2; AND 6) MATERNAL HEART RATE.THE STAN S31 FETAL HEART MONITOR FETAL ECG ANALYSIS FEATURE (ST ANALYSIS) ISINDICATED AS AN ADJUNCT TO FETAL HEART RATE MONITORING TO DETERMINE WHETHER OBSTETRICALINTERVENTION IS WARRANTED WHEN THERE IS INCREASED RISK OF DEVELOPING METABOLIC ACIDOSIS.ST ANALYSIS IS INTENDED FOR USE IN PATIENTS WITH:1) PLANNED VAGINAL DELIVERY;2) >36 WEEKS GESTATION;3) SINGLETON FETUS;4) VERTEX PRESENTATION; AND5) RUPTURED AMNIOTIC MEMBRANES.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HEO | Analyzer, Data, Obstetric | FDA class 3 | Obstetrics/Gynecology |