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

    AMPLIFE DIGITAL CLINICAL THERMOMETER

    K Number: K042575 · Decision Sep 30, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    4
    Review Days
    8

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    Basic Information

    Device Name
    AMPLIFE DIGITAL CLINICAL THERMOMETER
    K Number
    K042575
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Amplife Corporation
    Date Received
    September 22, 2004
    Decision Date
    September 30, 2004
    Product Code
    FLL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FLL Continuous Measurement Thermometer

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    Other Clearances by Amplife Corporation

    K Number Device Name
    K050413 AMPLIEF WRIST BLOOD PRESSURE MONITOR, MODEL M600
    K043550 AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100
    K042906 AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101