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

    ENTERSCAN

    K Number: K874081 · Decision Dec 31, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    3
    Applicant Total
    5
    Review Days
    85

    Basic Information

    Device Name
    ENTERSCAN
    K Number
    K874081
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Pie Data Medical BV
    Date Received
    October 7, 1987
    Decision Date
    December 31, 1987
    Product Code
    LWI
    Advisory Committee
    Radiology
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LWI Ultrasound, Sinus

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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
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    K871082 FETAL CARE MONITOR ANTEPARTUM 1500