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

    INFANT PHOTOTHERAPY MASK

    K Number: K813214 · Decision Dec 9, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    30

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    Basic Information

    Device Name
    INFANT PHOTOTHERAPY MASK
    K Number
    K813214
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5270
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Montrose Phototherapy Supply
    Date Received
    November 9, 1981
    Decision Date
    December 9, 1981
    Product Code
    FOK
    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
    FOK Pad, Neonatal Eye

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    Other Clearances by Montrose Phototherapy Supply

    K Number Device Name
    K813188 INFANT PHOTOTHERAPY LIGHT