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

    AIRWAYS (GUEDEL, BERMAN & NASOPHARYNGEAL TYPES)

    K Number: K890342 · Decision Apr 27, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    13
    Review Days
    94

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    Basic Information

    Device Name
    AIRWAYS (GUEDEL, BERMAN & NASOPHARYNGEAL TYPES)
    K Number
    K890342
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Eastmed Enterprises, Inc.
    Date Received
    January 23, 1989
    Decision Date
    April 27, 1989
    Product Code
    BTO
    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
    BTO Tube, Tracheostomy (W/Wo Connector)

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    Other Clearances by Eastmed Enterprises, Inc.

    K Number Device Name
    K922019 LARYNGOSCOPE RIGID
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    K914741 AMER PROFILE MILLER LARYNGOSCOPE BLADES, MODIFIED
    K903618 ROBERTAZZI NASOPHARYNGEAL AIRWAY
    K901489 MACINTOSH LARYNGOSCOPE BLADES (AMERICAN PROFILE)
    K884584 TONGUE SEIZING FORCEPS WITH & WITHOUT RUBBER PADS
    K884073 LARYNGOSCOPE BLADE (ROBERTSHAW STYLE)
    K884072 15 MILLIMETER MALE AND FEMALE ADAPTERS
    K882433 LARYNGOSCOPE RIGID
    K882434 MASK, GAS, ANESTHETIC
    Search all 13 clearances from Eastmed Enterprises, Inc. →