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

    AMSINO ENDOTRACHEAL TUBE

    K Number: K050785 · Decision Jul 15, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    240
    Applicant Total
    28
    Review Days
    109

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    Basic Information

    Device Name
    AMSINO ENDOTRACHEAL TUBE
    K Number
    K050785
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5730
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Amsino International, Inc.
    Date Received
    March 28, 2005
    Decision Date
    July 15, 2005
    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 Amsino International, Inc.

    K Number Device Name
    K252543 AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)
    K220230 AMSure Enteral Feeding Pump
    K220267 AMSafe NeuFlo Needleless Connector
    K213522 AMSafe Pre-Filled Normal Saline Flush Syringe
    K200051 PUGGLE Enteral Feeding Pump and Feeding Set
    K183473 AMSafe(R) Pre-Filled Normal Saline Flush Syringe
    K181445 AMSure Hydrophilic Intermittent Catheter
    K181423 AMSure Sterile Water, and Sterile Normal Saline for Wound Flush
    K173665 AMSafe Sure-Lok Needle-Free Connector
    K181814 AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water
    Search all 28 clearances from Amsino International, Inc. →