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

    HEALTHCHECK DIGITAL THERMOMETER MODEL 1 TH-2

    K Number: K851379 · Decision Apr 12, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    9
    Review Days
    4

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    Basic Information

    Device Name
    HEALTHCHECK DIGITAL THERMOMETER MODEL 1 TH-2
    K Number
    K851379
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Healthcheck Corp.
    Date Received
    April 8, 1985
    Decision Date
    April 12, 1985
    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 Healthcheck Corp.

    K Number Device Name
    K884489 C&T PREGNANCY TEST KIT
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    K881003 DIGITAL BLOOD PRESSURE MONITOR MODEL CX-1
    K863181 HEALTHCHECK THERM-STRIP
    K861946 PTK PLUS. HOME PREGNANCY TEST
    K860287 PULSONIC DIGITAL BLOOD PRESSURE MONITOR MODEL BP-3
    K850070 HEALTHCHECK AUTO INFLATE DIGITAL BP MONITOR BP-2
    K844281 PTK HEALTHCHECK PREGNANCY TEST KIT