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510(k) Data Aggregation

    K Number
    K982020
    Device Name
    METRON QA-IDS I.V. PUMP TESTER
    Manufacturer
    Date Cleared
    1998-09-30

    (113 days)

    Product Code
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    METRON U.S., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Metron QA-IDS Infusion Pump Tester is designed for use by trained service technicians, for testing all types of infusion purips. Tests include volumetric tests, and occlusion tests. The Metron-QA-IDS Infusion:Putmp;Tester is designed to be used by trained service technicians.
    Device Description
    Not Found
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    K Number
    K973991
    Device Name
    METRON QA-510 SPO2 ANALYZER
    Manufacturer
    Date Cleared
    1998-01-16

    (87 days)

    Product Code
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    METRON U.S., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Metron U.S. QA-510 SpO2 Analyzer is a precision instrument designed to perform tests on Pulse Oximeters. It also performs important measurements, such as the quality of the infrared LED and Red LED.
    Device Description
    The Metron U.S. QA-510 SpO2 Analyzer is a precision instrument designed to perform tests on Pulse Oximeters. It also performs important measurements, such as the quality of the infrared LED and Red LED.
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    K Number
    K963190
    Device Name
    QA-40M DEFIBRILLATOR TESTER
    Manufacturer
    Date Cleared
    1997-07-01

    (320 days)

    Product Code
    Regulation Number
    870.5325
    Why did this record match?
    Applicant Name (Manufacturer) :

    METRON U.S., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Metron U.S. OA-40M Defibrillator Analyzer is a precision instrument for testing defibrillators, and for ensuring that defibrillators comply with the specified requirements. The QA-40M tester is a device that is connected to the output of a defibrillator and is used to measure the energy delivered by the defibrillator into a standard resistive load and can also provide waveform information. The OA-40M test for ANSI/AAMI DF39 standards. The QA-40M Defibrillator Analyzer's main function is to measure the energy output of a defibrillator. The instrument has a built-in load resistance of 50 ohm, which roughly corresponds to the impedance of the human body. The defibrillator pads are placed on the OA-40M contact plates. Thus, the defibrillator is connected through load resistance, When the defibrillator is discharged. OA-40M will calculate and display the energy delivered. The OA-40M Defibrillator Analyzer performs the following tests and features (1) energy and cardioversion measurement, (2) peak voltage and current reading, (3) storage and playback of output waveform. (4) 12 lead ECG simulation. (5) ECG, performance and arrhythmia simulation, (6) transcutaneous cardiac pacemaker testing ( module is optional), (7) integrated pacemaker loads selectable from 50 ohm to 2500 ohm, (8) automatic defibrillator test procedures, (9) large graphic display and (10) RS-232C and Centronic printer interface.
    Device Description
    The QA-40M tester is a device that is connected to the output of a defibrillator and is used to measure the energy delivered by the defibrillator into a standard resistive load and can also provide waveform information. The OA-40M test for ANSI/AAMI DF39 standards. The QA-40M Defibrillator Analyzer's main function is to measure the energy output of a defibrillator. The instrument has a built-in load resistance of 50 ohm, which roughly corresponds to the impedance of the human body. The defibrillator pads are placed on the OA-40M contact plates. Thus, the defibrillator is connected through load resistance, When the defibrillator is discharged. OA-40M will calculate and display the energy delivered. The OA-40M Defibrillator Analyzer performs the following tests and features (1) energy and cardioversion measurement, (2) peak voltage and current reading, (3) storage and playback of output waveform. (4) 12 lead ECG simulation. (5) ECG, performance and arrhythmia simulation, (6) transcutaneous cardiac pacemaker testing ( module is optional), (7) integrated pacemaker loads selectable from 50 ohm to 2500 ohm, (8) automatic defibrillator test procedures, (9) large graphic display and (10) RS-232C and Centronic printer interface.
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    K Number
    K963198
    Device Name
    PS-41 6M PATIENT SIMULATOR
    Manufacturer
    Date Cleared
    1997-03-05

    (202 days)

    Product Code
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    METRON U.S., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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