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

    BPA CARDIOVASCULAR PRESSURE AMPLIFIER

    K Number: K870783 · Decision Apr 27, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    26
    Applicant Total
    3
    Review Days
    60

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    Basic Information

    Device Name
    BPA CARDIOVASCULAR PRESSURE AMPLIFIER
    K Number
    K870783
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2060
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Fisher Imaging Corp.
    Date Received
    February 26, 1987
    Decision Date
    April 27, 1987
    Product Code
    DRQ
    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
    DRQ Amplifier And Signal Conditioner, Transducer Signal

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    Other Clearances by Fisher Imaging Corp.

    K Number Device Name
    K952456 IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
    K853652 BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT