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

    Single-use Flexible Rhinolaryngoscope; Digital Video Monitor

    K Number: K230536 · Decision Jun 14, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    132
    Registration Numbers
    132
    Same Product Code
    161
    Applicant Total
    17
    Review Days
    107

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    Basic Information

    Device Name
    Single-use Flexible Rhinolaryngoscope; Digital Video Monitor
    K Number
    K230536
    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
    Hunan Vathin Medical Instrument Co., Ltd.
    Date Received
    February 27, 2023
    Decision Date
    June 14, 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 Hunan Vathin Medical Instrument Co., Ltd.

    K Number Device Name
    K250232 Vathin® Video Bronchoscope System
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    K250785 Single-use Flexible Ureteroscope
    K243117 Digital Video Processor
    K242416 Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL
    K242535 Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R); Digital Video Monitor (DVM-D1, DVM-D2)
    K241612 Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2)
    K240167 Single-use Ureteral Access Sheath
    K241434 Video Ureteroscope System
    K231135 Video Ureteroscope System
    Search all 17 clearances from Hunan Vathin Medical Instrument Co., Ltd. →