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

    UUHC REPROCESSED COMPRESSION SLEEVE DEVICES

    K Number: K031189 · Decision Oct 16, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    2
    Review Days
    184

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    Basic Information

    Device Name
    UUHC REPROCESSED COMPRESSION SLEEVE DEVICES
    K Number
    K031189
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    University of Utah Hospitals and Clinics
    Date Received
    April 15, 2003
    Decision Date
    October 16, 2003
    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 University of Utah Hospitals and Clinics

    K Number Device Name
    K080551 UNIVERSITY HEALTH CARE PROCESSED ALTERNATING LEG PRESSURE (UHC APL) SLEEVE DEVICE