FDA PMA
FDA Class 3
Approved (Withdrawn)
🇺🇸 United States
Oximeter, Fetal Pulse
PMA: P000016
·
Decision Feb 9, 2001
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Oximeter, Fetal Pulse
- Trade Name
- COROMETRICS 120F SERIES MATERNAL/FETAL MONITOR
- PMA Number
- P000016
- 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- Approved (Withdrawn)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
- February 9, 2001
- Date Received
- April 5, 2000
- Expedited Review
- N
- Docket Number
- 01M-0329
Advisory Committee Statement
APPROVAL FOR THE COROMETRICS MODEL 120 F-SERIES MATERNAL/FETAL MONITOR WITN INTEGRATED FETAL OXYGEN SATURATION MONITORING, COROMETRICS FETAL PATIENT MOFULE, AND THE NELLCOR OXIFIRST(TM) FS14 SENSOR. THE 120 F-SERIES SYSTEM CONTINUOUSLY MONITORS INTRAPARTUM FETAL OXYGEN SATURATION (FSPO2) AND 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 MATERNAL 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 |