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

    WA-2000 TEMPERATURE INDICATOR

    K Number: K813402 · Decision Jan 12, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    27
    Review Days
    39

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    Basic Information

    Device Name
    WA-2000 TEMPERATURE INDICATOR
    K Number
    K813402
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Wallach Surgical Devices, Inc.
    Date Received
    December 4, 1981
    Decision Date
    January 12, 1982
    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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