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

    (MT-27) THERMOMETER AND (M-10PC) PROBE COVERS

    K Number: K862333 · Decision Jul 8, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    10
    Review Days
    19

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    Basic Information

    Device Name
    (MT-27) THERMOMETER AND (M-10PC) PROBE COVERS
    K Number
    K862333
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Sharp Electronics Corp.
    Date Received
    June 19, 1986
    Decision Date
    July 8, 1986
    Product Code
    FLL
    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
    FLL Continuous Measurement Thermometer

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    Other Clearances by Sharp Electronics Corp.

    K Number Device Name
    K880715 (MB-650) BLOOD PRESSURE MONITOR
    K875093 NEW MODEL MB-550 BLOOD PRESSURE MONITOR
    K863672 MODEL (MB-700) BLOOD PRESSURE MONITOR
    K861375 MODEL MB-500 & MB-600 BLOOD PRESSURE MONITORS
    K852194 MODEL MT-50 DIGITAL MEMORY FEVER & BASAL THERMOMET
    K851664 MODEL MB-309H, SHARP DIGITAL BLOOD PRESSURE MONITO
    K850830 SHARP DIGITAL BP MONITOR MB-371H
    K842200 MD308H DIGITAL/MB351H AUTO-BP MONITOR
    K842199 ELEC. DIGITAL THERMOMETER MT-20 & 30