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

    CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P

    K Number: K101439 · Decision Feb 7, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    187
    Applicant Total
    7
    Review Days
    259

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    Basic Information

    Device Name
    CODONICS SAFE LABELING SYSTEM (SLS), MODEL 500I/500P
    K Number
    K101439
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5160
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Codonics, Inc.
    Date Received
    May 24, 2010
    Decision Date
    February 7, 2011
    Product Code
    BSZ
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BSZ Gas-Machine, Anesthesia

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    K003481 CODONICS NP-1660 SERIES MEDICAL PRINTERS, MODEL 1660
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