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

    NEONATE FLEXFLOAT

    K Number: K812683 · Decision Oct 13, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    5
    Applicant Total
    14
    Review Days
    21

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    Basic Information

    Device Name
    NEONATE FLEXFLOAT
    K Number
    K812683
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5560
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Pharmaquest Corp.
    Date Received
    September 22, 1981
    Decision Date
    October 13, 1981
    Product Code
    FOH
    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
    FOH Mattress, Water, Temperature Regulated

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