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

    AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS

    K Number: K940320 · Decision Sep 19, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    122
    Registration Numbers
    122
    Same Product Code
    18
    Applicant Total
    18
    Review Days
    603

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    Basic Information

    Device Name
    AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS
    K Number
    K940320
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5100
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ad-Tech Medical Instrument Corp
    Date Received
    January 24, 1994
    Decision Date
    September 19, 1995
    Product Code
    BTQ
    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
    BTQ Airway, Nasopharyngeal

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