BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇲🇾 Malaysia

    PEDIATRIC ENDOTRACHEAL TUBE

    K Number: K951697 · Decision May 22, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    240
    Applicant Total
    9
    Review Days
    40

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    Basic Information

    Device Name
    PEDIATRIC ENDOTRACHEAL TUBE
    K Number
    K951697
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5730
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Unomedical Sdn Bhd
    Date Received
    April 12, 1995
    Decision Date
    May 22, 1995
    Product Code
    BTR
    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
    BTR Tube, Tracheal (W/Wo Connector)

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    Other Clearances by Unomedical Sdn Bhd

    K Number Device Name
    K973076 EUROMEDICAL HAEMATURIA FOLEY CATHETER
    K962389 EUROMEDICAL REINFORCED ENDOTRACHEAL TUBE
    K954751 SILICONE ENDOTRACHEAL TUBE
    K954753 PEDIATRIC SILICONE ENDOTRACHEAL TUBE
    K954750 PEDIATRIC WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE
    K954754 WIRE REINFORCED SILICONE ENDOTRACHEAL TUBE
    K951696 ENDOTRACHEAL TUBE
    K945806 SILICATH ALL SILICONE FOLEY CATHETER