Oximeter, Fetal Pulse

Device Code: 4121

Product Code(s): MMA

Device Classification Information

Device Type ID4121
Device NameOximeter, Fetal Pulse
Review PanelObstetrics/Gynecology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD)
Obstetrics And Gynecology Devices Branch (OGDB)
Submission TypePMA
FDA Device ClassificationClass 3 Medical Device
Product CodeMMA
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4121
DeviceOximeter, Fetal Pulse
Product CodeMMA
FDA Device ClassificationClass 3 Medical Device
TPLC Last Update: 2019-04-02 20:43:21

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