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

    INFANT RADIANT WARMER

    K Number: K840792 · Decision May 25, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    91
    Applicant Total
    1
    Review Days
    92

    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
    INFANT RADIANT WARMER
    K Number
    K840792
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5130
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Hatch Bio Medical
    Date Received
    February 23, 1984
    Decision Date
    May 25, 1984
    Product Code
    FMT
    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
    FMT Warmer, Infant Radiant

    Similar 510(k) Clearances

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

    Babyroo TN300

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Babyroo TN300

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Giraffe Omnibed Carestation CS1

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Panda iRes Warmer, Giraffe Warmer

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Hydro-Temp Neonatal Skin Temperature Probe Cover

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