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

    DISP. NEONATAL BLOOD PRESSURE MONITORING CUFF

    K Number: K896788 · Decision Jan 19, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    172
    Registration Numbers
    172
    Same Product Code
    197
    Applicant Total
    5
    Review Days
    46

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    Basic Information

    Device Name
    DISP. NEONATAL BLOOD PRESSURE MONITORING CUFF
    K Number
    K896788
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Advanced Medical Instruments, Inc.
    Date Received
    December 4, 1989
    Decision Date
    January 19, 1990
    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

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    Other Clearances by Advanced Medical Instruments, Inc.

    K Number Device Name
    K923595 SYSTEM 7110 NON-INVASIVE BLOOD PRESSURE MONITOR
    K924910 SYSTEM 7500 NIBP/SA02
    K910521 SYSTEM 7300 PULSE OXIMETER
    K897173 SYSTEM 7100 NON-INVASIVE BLOOD PRESSURE MONITOR