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

    ELEC. DIGITAL THERMOMETER MT-20 & 30

    K Number: K842199 · Decision Jul 18, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    10
    Review Days
    44

    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
    ELEC. DIGITAL THERMOMETER MT-20 & 30
    K Number
    K842199
    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 4, 1984
    Decision Date
    July 18, 1984
    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

    Similar 510(k) Clearances

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

    Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Infrared Thermometer

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

    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
    K862333 (MT-27) THERMOMETER AND (M-10PC) PROBE COVERS
    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