FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Oximeter, Fetal Pulse
PMA: P990053
·
Supplement: S006
·
Decision Jan 7, 2003
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Oximeter, Fetal Pulse
- Trade Name
- OXIFIRST FETAL OXYGEN SATURATION MONITORING SYSTEM
- PMA Number
- P990053
- Supplement Number
- S006
- Device Class
- FDA Class 3
- Product Code
- MMA
- Generic Name
- Oximeter, fetal pulse
- Medical Specialty
- Unknown
- Advisory Committee
- Obstetrics/Gynecology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- January 7, 2003
- Date Received
- March 26, 2002
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR AN ALTERNATE MANUFACTURING SITE FOR THE N-400 FETAL PULSE OXIMETER. THE MANUFACTURING SITE IS LOCATED AT NELLCOR PURITAN BENNETT IRELAND, GALWAY, IRELAND.
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 |