BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    EPINAUT

    K Number: K173541 · Decision Aug 24, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    74
    Applicant Total
    6
    Review Days
    282

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    Basic Information

    Device Name
    EPINAUT
    K Number
    K173541
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5120
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Imedicom Co., Ltd.
    Date Received
    November 15, 2017
    Decision Date
    August 24, 2018
    Product Code
    BSO
    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
    BSO Catheter, Conduction, Anesthetic

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    Other Clearances by Imedicom Co., Ltd.

    K Number Device Name
    K182287 MEDINAUT Plus
    K153296 MEDINAUT Kyphoplasty System
    K150915 SPINAUT-P
    K151268 SPINAUT-V, SPINAUT-S, SPINAUT-I
    K150789 SPINAUT-E, SPINAUT-I