BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇭🇰 Hong Kong

    BT-338N ELECTRONIC CLINICAL THERMOMETER

    K Number: K894627 · Decision Oct 23, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    5
    Review Days
    91

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    Basic Information

    Device Name
    BT-338N ELECTRONIC CLINICAL THERMOMETER
    K Number
    K894627
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Integrated Display Technology, Ltd.
    Date Received
    July 24, 1989
    Decision Date
    October 23, 1989
    Product Code
    FCI
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FCI Punch, Biopsy

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    Other Clearances by Integrated Display Technology, Ltd.

    K Number Device Name
    K951977 DIGITAL BLOOD PRESSURE METER - MODEL NO.: BPM883
    K941490 BLOOD PRESSURE METER MODEL NO. BPM888
    K942336 AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
    K853130 INTEGRATED DISPLAY TECHNOLOGY LTD.