BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    HD-550 Video Endoscope System

    K Number: K211882 · Decision Apr 1, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    8
    Applicant Total
    1
    Review Days
    284

    Basic Information

    Device Name
    HD-550 Video Endoscope System
    K Number
    K211882
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sonoscape Medical Corp
    Date Received
    June 21, 2021
    Decision Date
    April 1, 2022
    Product Code
    NWB
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NWB Endoscope, Accessories, Narrow Band Spectrum

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