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

    BABY LIGHT DOSIMETER

    K Number: K832298 · Decision Oct 19, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    70
    Applicant Total
    9
    Review Days
    97

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    BABY LIGHT DOSIMETER
    K Number
    K832298
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5700
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Rocky Mountain Medical Corp.
    Date Received
    July 14, 1983
    Decision Date
    October 19, 1983
    Product Code
    LBI
    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
    LBI Unit, Neonatal Phototherapy

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LBI), ordered by most recent decision date.

    SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BiliWrap

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Infant Phototherapy Equipment

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Neonatal Phototherapy System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    bili-hut

    FDA 510(k)
    FDA Class 2 ·General Hospital

    neoBLUE blanket LED Phototherapy System

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Rocky Mountain Medical Corp.

    K Number Device Name
    K890202 TELE-TEMP THERMOMETER
    K860120 NURSERY AMBIENT LIGHT METER
    K852167 ISOVOL-EXCHANGE TRAY
    K853970 ALPHA CHUCK
    K853790 BABE SHADE-INFANT AMBIENT LIGHT INTENSITY REDUCER
    K851876 PREFER INCONTINENCE AID
    K834430 OMNI INFANT PHOTOTHERAPY UNIT
    K837494 BABY LIGHT METER