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

    NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR

    K Number: K952824 · Decision Jul 20, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    161
    Registration Numbers
    161
    Same Product Code
    93
    Applicant Total
    1
    Review Days
    30

    Basic Information

    Device Name
    NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR
    K Number
    K952824
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5810
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    INTERTEX MEDICAL, INC.
    Date Received
    June 20, 1995
    Decision Date
    July 20, 1995
    Product Code
    BZA
    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
    BZA Connector, Airway (Extension)

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