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

    PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System

    K Number: K213235 · Decision Dec 21, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    158
    Registration Numbers
    158
    Same Product Code
    226
    Applicant Total
    32
    Review Days
    447

    Basic Information

    Device Name
    PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System
    K Number
    K213235
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    PENTAX of America, Inc.
    Date Received
    September 30, 2021
    Decision Date
    December 21, 2022
    Product Code
    EOQ
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EOQ Bronchoscope (Flexible Or Rigid)

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    K220465 PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10
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