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

    NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY

    K Number: K911784 · Decision Sep 23, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    122
    Registration Numbers
    122
    Same Product Code
    18
    Applicant Total
    16
    Review Days
    154

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    Basic Information

    Device Name
    NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY
    K Number
    K911784
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5100
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    North American Sterilization & Packaging Co.
    Date Received
    April 22, 1991
    Decision Date
    September 23, 1991
    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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    Other Clearances by North American Sterilization & Packaging Co.

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    K963753 NASP TRANSPARENT DRESSING
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    K925588 NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI
    K925593 NORTEC STERILE WATER FOR DEVICE IRRIGATION
    K925161 NORTEC STERILE WATER FOR CATHETER BALLOON INFLATIO
    K911865 NORTEC CONNECTING TUBE SET
    K910691 NORTEC URETERAL STENT
    K903162 FLEXIBLE ENDOSCOPIC ELECTRODES
    K903156 CONTROL-TIP CYSTOSCOPIC ELECTRODES
    Search all 16 clearances from North American Sterilization & Packaging Co. →