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

    21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01)

    K Number: K233336 · Decision May 21, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    134
    Applicant Total
    2
    Review Days
    235

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    Basic Information

    Device Name
    21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01)
    K Number
    K233336
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.2050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Acula Technology Corp.
    Date Received
    September 29, 2023
    Decision Date
    May 21, 2024
    Product Code
    PGY
    Advisory Committee
    Radiology
    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
    PGY Display, Diagnostic Radiology

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    Other Clearances by Acula Technology Corp.

    K Number Device Name
    K241499 21.3” 5MP Color LCD Display UMD5-21B01