FDA PMA
FDA Class 3
Approved (Withdrawn)
🇺🇸 United States
Oximeter, Fetal Pulse
PMA: P020028
·
Decision Jan 3, 2003
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Oximeter, Fetal Pulse
- Trade Name
- SERIES 50 XMO (MODEL M1350C) FETAL/MATERNAL MONITOR SYSTEM WITH INTEGRATED FETAL OXYGEN SATURATION MONITORING
- PMA Number
- P020028
- Device Class
- FDA Class 3
- Product Code
- MMA
- Generic Name
- Oximeter, fetal pulse
- Medical Specialty
- Unknown
- Advisory Committee
- Obstetrics/Gynecology
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- January 3, 2003
- Date Received
- July 9, 2002
- Expedited Review
- N
- Docket Number
- 03M-0241
Advisory Committee Statement
APPROVAL FOR THE SERIES 50 XMO (MODEL M1350C) FETAL/MATERNAL MONITOR SYSTEM WITH INTEGRATED FETAL OXYGEN SATURATION MONITORING, M1365A FETAL SPO2 PATIENT MODULE, AND THE NELLCOR OXIFIRST FS14 SENSOR. THIS DEVICE IS INTENDED FOR CONTINUOUS MONITORING OF INTRAPARTUM FETAL OXYGEN SATURATION (FSPO2) AND THE FSPO2 PARAMETER IS INDICATED AS AN ADJUNCT TO FETAL HEART RATE (FHR) MONITORING IN THE PRESENCE OF A NONREASSURING FETAL HEART RATE PATTERN. IT SHOULD ONLY BE USED AFTER AMNIOTIC MEMBRANES HAVE RUPTURED AND ON A SINGLETON FETUS IN VERTEX PRESENTATION WITH A GESTATIONAL AGE GREATER THAN OR EQUAL TO 36 WEEKS.
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 |
|---|---|---|---|
| MMA | Oximeter, Fetal Pulse | FDA class 3 | Unknown |