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

    BRAUN THERMOSCAN PRO-2000 INSTANT THERMOMETER (PRO-2000)

    K Number: K964605 · Decision May 16, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    488
    Registration Numbers
    488
    Same Product Code
    797
    Applicant Total
    5
    Review Days
    179

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    Basic Information

    Device Name
    BRAUN THERMOSCAN PRO-2000 INSTANT THERMOMETER (PRO-2000)
    K Number
    K964605
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2910
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Thermoscan, Inc.
    Date Received
    November 18, 1996
    Decision Date
    May 16, 1997
    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 Thermoscan, Inc.

    K Number Device Name
    K954523 THERMOSCAN INSTANT THERMOMETER MODEL IR-6000
    K930680 THERMOSCAN INSTANT THERMOMETER IR-5000
    K902912 THERMOSCAN-INSTANT THERMOMETER MODEL IR-4000
    K896952 THERMOSCAN-INSTANT THERMOMETER MODEL IR-2000