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

    DORO HEADREST SYSTEM

    K Number: K001808 · Decision Aug 4, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    49
    Applicant Total
    4
    Review Days
    50

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    Basic Information

    Device Name
    DORO HEADREST SYSTEM
    K Number
    K001808
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4460
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pro-Med Instruments GmbH
    Date Received
    June 15, 2000
    Decision Date
    August 4, 2000
    Product Code
    HBL
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HBL Holder, Head, Neurosurgical (Skull Clamp)

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    Other Clearances by Pro-Med Instruments GmbH

    K Number Device Name
    K063494 DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS
    K070997 DORO NON-STICK BIPOLAR FORCEPS, MODEL 5001-XX TO 5012-XX, DORO BIPOLAR REUSABLE CABLES, MODEL 5015-XX
    K032331 DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY)