BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DORMIE NECK SUPPORT SYSTEM

    K Number: K930730 · Decision Jul 22, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    297
    Registration Numbers
    297
    Same Product Code
    26
    Applicant Total
    1
    Review Days
    161

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    Basic Information

    Device Name
    DORMIE NECK SUPPORT SYSTEM
    K Number
    K930730
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3490
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    The Western Diagnostics Co.
    Date Received
    February 11, 1993
    Decision Date
    July 22, 1993
    Product Code
    IQK
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IQK Orthosis, Cervical

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