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

    TEMPERATURE PROBE-TP350

    K Number: K952803 · Decision Apr 4, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    91
    Applicant Total
    9
    Review Days
    290

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    Basic Information

    Device Name
    TEMPERATURE PROBE-TP350
    K Number
    K952803
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5130
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Contour Medical Technology, Inc.
    Date Received
    June 19, 1995
    Decision Date
    April 4, 1996
    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

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    Other Clearances by Contour Medical Technology, Inc.

    K Number Device Name
    K970391 QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES
    K970125 NOAH MONITORING ELECTRODE SYSTEM
    K960329 DISPOSABLE HYDROGEL DEFIBRILLATION ELECTRODE/PAD
    K952805 TEMPERATURE PROBE-TP550
    K952807 TEMPERATURE PROBE-TP650
    K952801 TEMPERATURE PROBE-TP250
    K952800 TEMPERATURE PROBE-TP150
    K952804 TEMPERATURE PROBE-TP450