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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    RXS 1000

    K Number: K202369 · Decision Sep 15, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    205
    Applicant Total
    2
    Review Days
    392

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    Basic Information

    Device Name
    RXS 1000
    K Number
    K202369
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1800
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rolence Enterprise, Inc.
    Date Received
    August 19, 2020
    Decision Date
    September 15, 2021
    Product Code
    MUH
    Advisory Committee
    Dental
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MUH System, X-Ray, Extraoral Source, Digital

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    Other Clearances by Rolence Enterprise, Inc.

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