BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    THE CELL CARE SYSTEM

    K Number: K860537 · Decision Apr 17, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    30
    Applicant Total
    1
    Review Days
    65

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    Basic Information

    Device Name
    THE CELL CARE SYSTEM
    K Number
    K860537
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.2400
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    The Clell Corp.
    Date Received
    February 11, 1986
    Decision Date
    April 17, 1986
    Product Code
    KMI
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KMI Monitor, Bed Patient

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