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

    TEMPERATURE MONITOR 130/131/133

    K Number: K812037 · Decision Jul 28, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    14
    Review Days
    7

    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
    TEMPERATURE MONITOR 130/131/133
    K Number
    K812037
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Medix Medical Electronics (U.S.A.), Inc.
    Date Received
    July 21, 1981
    Decision Date
    July 28, 1981
    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 Medix Medical Electronics (U.S.A.), Inc.

    K Number Device Name
    K861040 ENTERNAL INFUSER MULTIPUMP 203
    K861001 PARENTERAL INFUSER MEDIPUMP 204
    K853393 INSULIN PUMP INSUMAT 229
    K852433 INFUSAFE 205 CATOLOG NO. 205.000
    K813562 SYRINGE DRIVER 209
    K812039 SPIROMETER 210/211
    K812041 VENTI-MONITOR MODEL 101
    K812045 INFANT APNEA MONITOR MODEL 100
    K812040 OXYGEN MONITOR 140/141
    K812046 TIDAL VOLUME MONITOR 150
    Search all 14 clearances from Medix Medical Electronics (U.S.A.), Inc. →