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

    PRESSURE MANOMETER

    K Number: K841071 · Decision Apr 17, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    258
    Same Product Code
    763
    Applicant Total
    4
    Review Days
    36

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    Basic Information

    Device Name
    PRESSURE MANOMETER
    K Number
    K841071
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Interventional Medical, Inc.
    Date Received
    March 12, 1984
    Decision Date
    April 17, 1984
    Product Code
    DQX
    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
    DQX Wire, Guide, Catheter

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    Other Clearances by Interventional Medical, Inc.

    K Number Device Name
    K880831 LARGE LUMEN Y ADAPTER W/ROTATING DEVICE
    K830609 INFLATION DEVICE
    K822243 GUIDING CATHETER