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

    AMETHERM

    K Number: K840526 · Decision Apr 30, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    84
    Applicant Total
    10
    Review Days
    83

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    Basic Information

    Device Name
    AMETHERM
    K Number
    K840526
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5400
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Egnell, Inc.
    Date Received
    February 7, 1984
    Decision Date
    April 30, 1984
    Product Code
    FMZ
    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
    FMZ Incubator, Neonatal

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