Product Code: MMA
FDA class 3
Oximeter, Fetal Pulse
Unknown
The Fetal Pulse Oximeter is a device used during labor and delivery to non-invasively monitor the oxygen saturation of fetal blood, typically by attaching a sensor to the fetal presenting part, providing real-time assessment of fetal oxygenation to guide obstetric management during labor. As a Class 3 device, it requires Premarket Approval (PMA) reflecting the significant risks associated with fetal monitoring and the critical nature of its intended clinical application. No regulation number or medical specialty code is recorded, and it carries no implant or life-sustaining flags.
510(k)s
0
FEI Numbers
0
Registration Numbers
0
Unique Applicants
0
Years Active
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Basic Information
- Product Code
- MMA
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- OB
- Submission Type
- 2
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
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Summary Malfunction Reporting