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

    SLM-1ER, SLM-2ER, SLM-3ER

    K Number: K171877 · Decision Dec 21, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    55
    Same Product Code
    107
    Applicant Total
    1
    Review Days
    181

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SLM-1ER, SLM-2ER, SLM-3ER
    K Number
    K171877
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1850
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chongqing Kanghua Ruiming S&T Co., Ltd.
    Date Received
    June 23, 2017
    Decision Date
    December 21, 2017
    Product Code
    HJO
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HJO Biomicroscope, Slit-Lamp, Ac-Powered

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HJO), ordered by most recent decision date.

    VISUREF 600

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    HP-OCT (HP-OCT)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Kowa SL-19

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MiiS Horus Eye Anterior Camera

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Sunkingdom Slit Lamp

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    IOLMaster 700

    FDA 510(k)
    FDA Class 2 ·Ophthalmic
    View all