BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MULTIPLE, MODEL KTJ-50

    K Number: K043444 · Decision Feb 22, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    172
    Registration Numbers
    172
    Same Product Code
    197
    Applicant Total
    2
    Review Days
    70

    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
    MULTIPLE, MODEL KTJ-50
    K Number
    K043444
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Golden Horse Medical Equipment (Wuxi) Co. , Ltd.
    Date Received
    December 14, 2004
    Decision Date
    February 22, 2005
    Product Code
    DXQ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DXQ Blood Pressure Cuff

    Similar 510(k) Clearances

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

    YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Disposable Neonatal NIBP Cuff (U1681S-C51N)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AViTA Arm Type Blood Pressure Monitor Cuff

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N)

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

    Other Clearances by Golden Horse Medical Equipment (Wuxi) Co. , Ltd.

    K Number Device Name
    K010686 KTJ-20C BLOOD PRESSURE CUFF, MODEL KTJ-20C