BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PRESSURE ISOLATION AMPLIFIER #9813 517

    K Number: K822590 · Decision Oct 4, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    3
    Applicant Total
    69
    Review Days
    27

    Basic Information

    Device Name
    PRESSURE ISOLATION AMPLIFIER #9813 517
    K Number
    K822590
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.2600
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    HONEYWELL, INC.
    Date Received
    September 7, 1982
    Decision Date
    October 4, 1982
    Product Code
    DRJ
    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
    DRJ System, Signal Isolation

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