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

    PIE MEDICAL SCANNER 1000

    K Number: K870058 · Decision Feb 2, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    59
    Applicant Total
    5
    Review Days
    391

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    Basic Information

    Device Name
    PIE MEDICAL SCANNER 1000
    K Number
    K870058
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2660
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Pie Data Medical BV
    Date Received
    January 7, 1987
    Decision Date
    February 2, 1988
    Product Code
    KNG
    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
    KNG Monitor, Ultrasonic, Fetal

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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
    K874081 ENTERSCAN
    K871082 FETAL CARE MONITOR ANTEPARTUM 1500