BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    FETAL CARE MONITOR ANTEPARTUM 1500

    K Number: K871082 · Decision Aug 4, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    213
    Applicant Total
    5
    Review Days
    139

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    Basic Information

    Device Name
    FETAL CARE MONITOR ANTEPARTUM 1500
    K Number
    K871082
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2740
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Pie Data Medical BV
    Date Received
    March 18, 1987
    Decision Date
    August 4, 1987
    Product Code
    HGM
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HGM System, Monitoring, Perinatal

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    Other Clearances by Pie Data Medical BV

    K Number Device Name
    K874192 MULTIPURPOSE TRANSDUCER RANGE
    K870653 ULTRASOUND LINEAR/SECTOR SCANNER 1100
    K870058 PIE MEDICAL SCANNER 1000
    K874081 ENTERSCAN