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510(k) Data Aggregation

    K Number
    K961404
    Manufacturer
    Date Cleared
    1996-06-27

    (77 days)

    Product Code
    Regulation Number
    870.2850
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MX960 REUSABLE PRESSURE TRANSDUCER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MX960 reusable pressure transducer is used to convert hemodynamic pressure waveforms via a piezoresistive bridge circuit into electrical signals which can then be displayed using separate monitoring equipment.

    Device Description

    The MX960 reusable pressure transducer is a non-fluid pathway device. A pressure waveform is conveyed through a disposable dome which is coupled to the reusable pressure transducer during pressure monitoring. Both the transducer and dome have mutually exclusive diaphragms. Accordingly, fluid contact is limited to the dome portion of the system. The materials which comprise the MX960 have been aggressively tested per the ANSVAAMI/ISO 10993 "Biological Evaluation of Medical Devices" and the "Tripartite Biocompatibility Guidance for Medical Devices". All materials have successfully met these standards.

    AI/ML Overview

    The Medex, Inc. MX960 Reusable Pressure Transducer underwent performance testing against the ANSI/AAMI BP22-1994 standard for blood pressure transducers.

    Here's a breakdown of the acceptance criteria and the study details:

    1. Acceptance Criteria and Reported Device Performance

    PARAMETERAAMI SPECIFICATION (Acceptance Criteria)MX960 Performance (Reported Device Performance)
    Sensitivity - µV/V/mmHgDisclosure5.0 Nominal
    Unbalance - mmHg0 ± 750 ± 50
    Zero Drift - mmHgDisclosure≤ 2 in 4 hrs after 5 min
    Input Impedance - OHMS200300 ± 10%
    Calibration Requirement - mmHgNot Specified100 ± 3
    Accuracy - mmHg
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