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

    ENDOCARE ELECTORNIC THERMOMETER SYSTEM

    K Number: K961365 · Decision Aug 15, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    518
    Registration Numbers
    518
    Same Product Code
    795
    Applicant Total
    22
    Review Days
    128

    Basic Information

    Device Name
    ENDOCARE ELECTORNIC THERMOMETER SYSTEM
    K Number
    K961365
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ENDOCARE, INC.
    Date Received
    April 9, 1996
    Decision Date
    August 15, 1996
    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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