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

    AMADEUS ADAPTIVE COMPRESSION THERAPY

    K Number: K071763 · Decision Mar 7, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    7
    Review Days
    252

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    Basic Information

    Device Name
    AMADEUS ADAPTIVE COMPRESSION THERAPY
    K Number
    K071763
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Convatec
    Date Received
    June 29, 2007
    Decision Date
    March 7, 2008
    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 Convatec

    K Number Device Name
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    K083785 VITALA CONTINENCE CONTROL DEVICE
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