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

    PHLEBOPUMP, MODEL 1000

    K Number: K003284 · Decision Jan 17, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    129
    Registration Numbers
    129
    Same Product Code
    349
    Applicant Total
    3
    Review Days
    90

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    Basic Information

    Device Name
    PHLEBOPUMP, MODEL 1000
    K Number
    K003284
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Prevent Products, Inc.
    Date Received
    October 19, 2000
    Decision Date
    January 17, 2001
    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 Prevent Products, Inc.

    K Number Device Name
    K952975 ANKLE CALF EXERCISER PHLEBOPUMP
    K942618 ANKLE CALF EXERCISER