BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    Medical Monitor (27HS714S)

    K Number: K243439 · Decision Jan 28, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    27
    Review Days
    83

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    Basic Information

    Device Name
    Medical Monitor (27HS714S)
    K Number
    K243439
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lg Electronics.Inc
    Date Received
    November 6, 2024
    Decision Date
    January 28, 2025
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Lg Electronics.Inc

    K Number Device Name
    K261213 Medical Monitor (40HT513D)
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    K233599 X-Clever (ASHK100G)
    K240130 Medical Monitor (21HQ613D)
    K232985 24HR513C
    K232127 21HQ513D, 32HL512D, 31HN713D, 32HQ713D
    K230845 32HL512D, 31HN713D, 32HQ713D
    K223423 32HQ713D
    K223546 14HQ721G-B
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