BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    PatCom Distal Chip Endoscope

    K Number: K222587 · Decision Jul 28, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    161
    Applicant Total
    2
    Review Days
    336

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    Basic Information

    Device Name
    PatCom Distal Chip Endoscope
    K Number
    K222587
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4760
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    H&A Mui Enterprises, Inc.
    Date Received
    August 26, 2022
    Decision Date
    July 28, 2023
    Product Code
    EOB
    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
    EOB Nasopharyngoscope (Flexible Or Rigid)

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    Other Clearances by H&A Mui Enterprises, Inc.

    K Number Device Name
    K192691 PatCom Single-Use Introducer