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

    SIMS HYPERINFLATION BAG SYSTEM

    K Number: K970785 · Decision Jun 13, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    9
    Applicant Total
    2
    Review Days
    101

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    Basic Information

    Device Name
    SIMS HYPERINFLATION BAG SYSTEM
    K Number
    K970785
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sims
    Date Received
    March 4, 1997
    Decision Date
    June 13, 1997
    Product Code
    NHK
    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
    NHK Resuscitator, Manual, Non Self-Inflating

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    Other Clearances by Sims

    K Number Device Name
    K972283 SIMS 1ST RESPONSE MANUAL RESUSCITATOR, ADULT