BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    PBS MODEL 701A COMPRESSION THERAPY DEVICE

    K Number: K060220 · Decision Feb 9, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    5
    Review Days
    10

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    Basic Information

    Device Name
    PBS MODEL 701A COMPRESSION THERAPY DEVICE
    K Number
    K060220
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mego Afek
    Date Received
    January 30, 2006
    Decision Date
    February 9, 2006
    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 Mego Afek

    K Number Device Name
    K230385 Ballancer Platinum (1222)
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