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

    REPRO-MED NEONATE ASPIRATION SYSTEM

    K Number: K892529 · Decision Jun 12, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    245
    Registration Numbers
    245
    Same Product Code
    115
    Applicant Total
    6
    Review Days
    62

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    Basic Information

    Device Name
    REPRO-MED NEONATE ASPIRATION SYSTEM
    K Number
    K892529
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.6810
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Repro-Med Systems, Inc.
    Date Received
    April 11, 1989
    Decision Date
    June 12, 1989
    Product Code
    BSY
    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
    BSY Catheters, Suction, Tracheobronchial

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