Monitor, Fetal Doppler Ultrasound

Device Code: 5268

Product Code(s): MAA

Device Classification Information

Device Type ID5268
Device NameMonitor, Fetal Doppler Ultrasound
Regulation DescriptionFetal Ultrasonic Monitor And Accessories.
Regulation Medical SpecialtyObstetrics/Gynecology
Review PanelRadiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number884.2660 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeMAA
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID5268
DeviceMonitor, Fetal Doppler Ultrasound
Product CodeMAA
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionFetal Ultrasonic Monitor And Accessories.
CFR Regulation Number884.2660 [🔎]
TPLC Last Update: 2019-04-02 21:03:23

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