FDA product code MMA: Oximeter, Fetal Pulse

MMA is the FDA product code for oximeter, fetal pulse. It is a Class III device, reviewed by the Obstetrics and Gynecology panel. Devices under MMA reach the market by PMA; FDA lists no cleared 510(k)s for it. 3 PMA applications cite this product code.

Classification

FieldValue
Device nameOximeter, Fetal Pulse
Device classClass III
Review panelOB — Obstetrics and Gynecology
Medical specialtyUnknown
Premarket routePMA

Recalls for MMA devices

openFDA lists no recalls for product code MMA.

Frequently asked questions

What is FDA product code MMA?

MMA is the FDA product code for oximeter, fetal pulse. It is a Class III device, reviewed by the Obstetrics and Gynecology panel.

What device class is MMA?

Class III. Typical premarket route: PMA.

Next steps

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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