PMA P020028
- Device
- SERIES 50 XMO (MODEL M1350C) FETAL/MATERNAL MONITOR SYSTEM WITH INTEGRATED FETAL OXYGEN SATURATION MONITORING
- Applicant
- Philips Medical Systems, Inc.
- PMA number
- P020028
- Product code
- MMA
- Decision date
- 2003-01-03
- Classification
- Obstetrics/Gynecology
- Generic name
- Oximeter, fetal pulse
- Approval order 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.
Current openFDA PMA Record#
- Device
- SERIES 50 XMO (MODEL M1350C) FETAL/MATERNAL MONITOR SYSTEM WITH INTEGRATED FETAL OXYGEN SATURATION MONITORING
- Applicant
- Philips Medical Systems, Inc.
- PMA number
- P020028
- Product code
- MMA
- Generic name
- Oximeter, fetal pulse
- Decision date
- 2003-01-03
- Decision code
- APWD
- Date received
- 2002-07-09
- Approval order 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.