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

    NEEDLECRIC

    K Number: K914471 · Decision Jun 29, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    108
    Applicant Total
    2
    Review Days
    265

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    Basic Information

    Device Name
    NEEDLECRIC
    K Number
    K914471
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ajs Medical Co., Inc.
    Date Received
    October 8, 1991
    Decision Date
    June 29, 1992
    Product Code
    JOH
    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
    JOH Tube Tracheostomy And Tube Cuff

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    Other Clearances by Ajs Medical Co., Inc.

    K Number Device Name
    K925288 TRACHEOSTOMY KIT