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

    AeroDVx System

    K Number: K183349 · Decision Jul 19, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    2
    Review Days
    228

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    Basic Information

    Device Name
    AeroDVx System
    K Number
    K183349
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sun Scientific, Inc.
    Date Received
    December 3, 2018
    Decision Date
    July 19, 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 Sun Scientific, Inc.

    K Number Device Name
    K222823 AeroDVx Arm System