BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING

    K Number: K992811 · Decision Jan 18, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    22
    Applicant Total
    13
    Review Days
    151

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    Basic Information

    Device Name
    TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING
    K Number
    K992811
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    884.2720
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Epic Medical Equipment Services, Inc.
    Date Received
    August 20, 1999
    Decision Date
    January 18, 2000
    Product Code
    HFM
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HFM Monitor, Uterine Contraction, External (For Use In Clinic)

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    Other Clearances by Epic Medical Equipment Services, Inc.

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    K002223 EPIC SPO2 FINGER SENSOR, MODEL E412-20
    K000831 STAT-SHELL DISPOSABLE SP02 SENSOR
    K992211 SPO2 WRAP SENSOR
    K992092 STAT-SHELL DISPOSABLE SPO2 SENSOR
    K990082 EPIC SPO2 FINGER SENSOR, MODEL E403-09, E412-09 AND EPIC OXIMETER CABLE, MODEL E710-09
    K970098 E100 SERIES SPO2 SENSORS
    K965172 OXIMETER PRE-AMP CABLE
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