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

    HUNTLEIGH FLOWPAC FP2000

    K Number: K871272 · Decision Jun 25, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    44
    Applicant Total
    23
    Review Days
    86

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    Basic Information

    Device Name
    HUNTLEIGH FLOWPAC FP2000
    K Number
    K871272
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Huntleigh Technology, Inc.
    Date Received
    March 31, 1987
    Decision Date
    June 25, 1987
    Product Code
    DRM
    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
    DRM Compressor, Cardiac, External

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