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

    LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET

    K Number: K873435 · Decision Oct 5, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    237
    Applicant Total
    5
    Review Days
    40

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    Basic Information

    Device Name
    LEVEL 1 IR-600 NORMOTHERMIC IRRIGATING SET
    K Number
    K873435
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Level 1 Technologies, Inc.
    Date Received
    August 26, 1987
    Decision Date
    October 5, 1987
    Product Code
    KOD
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KOD Catheter, Urological

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    Other Clearances by Level 1 Technologies, Inc.

    K Number Device Name
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    K911383 HOTLINE FLUID WARMER