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

    Radial Medical Compression System

    K Number: K190976 · Decision Jul 12, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    2
    Review Days
    88

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    Basic Information

    Device Name
    Radial Medical Compression System
    K Number
    K190976
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Radial Medical, Inc.
    Date Received
    April 15, 2019
    Decision Date
    July 12, 2019
    Product Code
    JOW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JOW Sleeve, Limb, Compressible

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    Other Clearances by Radial Medical, Inc.

    K Number Device Name
    K181651 Radial Medical Compression System