BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    HCI TUBE STABILIZER

    K Number: K942529 · Decision Jun 14, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    142
    Registration Numbers
    142
    Same Product Code
    46
    Applicant Total
    1
    Review Days
    383

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    Basic Information

    Device Name
    HCI TUBE STABILIZER
    K Number
    K942529
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5770
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Health Care Contracts, Inc.
    Date Received
    May 27, 1994
    Decision Date
    June 14, 1995
    Product Code
    CBH
    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
    CBH Device, Fixation, Tracheal Tube

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