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

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
Summary Malfunction Reporting