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510(k) Data Aggregation

    K Number
    K213872
    Device Name
    ComPAS2
    Manufacturer
    Morgan Scientific, Inc.
    Date Cleared
    2022-07-15

    (214 days)

    Product Code
    BZG
    Regulation Number
    868.1840
    Why did this record match?
    Applicant Name (Manufacturer) :

    Morgan Scientific, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Morgan Scientific's ComPAS2 is a software application intended to be used to compatible Morgan Scientific or thirdparty devices to acquire, analyze, view, store, export, and print the device outputs including measurements of flow, volume, pressure, and gas concentrations. The product is designed for use on adults and pediatrics 4 years and older, in a variety of healthcare environments such as, but not limited to, primary care, hospitals, and research health centers under the supervision of a healthcare provider.
    Device Description
    ComPAS2 is a software application designed to provide a secure PC based medical device for creating, adding/recalling subjects, and performing cardio-pulmonary function testing on those subjects. ComPAS2 will interface and link to compatible Morgan Scientific and third-party devices to read, analyze, and display their output to allow the information to be retained with the subject. Current compatible approved devices: TransAir (K953990), SpiroAir (K042595), Body Plethysmograph (K022636), WristOx2 (K102350), tremoFlo (K170185), Pneumotrac (K142812), Micro (K160253), Model 9100 PFT/D1CO (K221030). Data can be reported directly to a printer or communicated with hospital information systems/electronic medical records. All data are preserved in an SQL database, with key sub-systems of ComPAS2 interacting with the database through an API (Application Program Interface). ComPAS2 is designed to operate with compatible cardio-pulmonary function testing hardware by manufacturers offering the capability to measure key pulmonary functions including, but not limited to: static and dynamic spirometry, bronchial challenge, maximum voluntary ventilation, respiratory muscle strength, cough peak flow, lung volume sub-divisions (such as but not limited to helium dilution, nitrogen washout and plethysmography), single breath diffusion, airway resistance, distribution with lung clearance index closing volume. Other features include: a task manager to manage patient data for reporting; manual entry to input additional information; and historical data review to analyze data for trending and reporting.
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    K Number
    K190568
    Device Name
    ComPAS2 (Computerized Pulmonary Analysis System)
    Manufacturer
    Morgan Scientific, Inc.
    Date Cleared
    2019-06-06

    (92 days)

    Product Code
    BZG
    Regulation Number
    868.1840
    Why did this record match?
    Applicant Name (Manufacturer) :

    Morgan Scientific, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ComPAS2 software is intended to operate with the Screenstar pneumotachograph spirometer, Morgan Transflow test PFT system and the Morgan transfer test benchmark PFT system. ComPAS2 uses flow and volume from each of the devices to display the flow and volume information measured directly from patient effort. ComPAS2 also utilizes gas analyzer readings from the Transfer test benchmark to display helium dilution lung volume data and single breath diffusion data measured directly from patient effort. This information is for use in pulmonary function testing and reports.
    Device Description
    ComPAS2 is designed to interface with various pieces of hardware (previously cleared pulmonary function testing devices, K142812, K042595, K022636, K953990, K013752) to capture clinical data in the performance of clinical testing. Those data can be reported directly to a printer or communicated with hospital information systems/electronic medical records. All data are preserved in an SOL database, with key sub-systems of ComPAS2 interacting with the database through an API (Application Program Interface). ComPAS2 is designed to operate with pulmonary function testing hardware by manufacturers offering the capability to measure key pulmonary functions including: static and dynamic spirometry, bronchial challenge, maximum voluntary ventilation (MVV), respiratory muscle strength, cough peak flow, lung volume sub-divisions (by helium dilution, nitrogen washout and plethysmography), single breath diffusion, airway resistance, distribution with lung clearance index closing volume. Other features include a task manager in order to manage patient data for reporting, manual entry in order to input additional information and historical data in order to analyze data for trending and reporting. The user performs daily quality checks/calibrations prior to performing any tests. Once the test subject enters the Pulmonary Function Testing lab, foundation biographical information (Unique ID, Name, DOB) are either entered by the user, recalled or received in and order via Health Level 7(HL7) message from the information system. The functionality of ComPAS2 software remains the same as the predicate and provides the end user with the same experience. Encounter information is added at the time of testing such as height, weight, diagnosis and physician. Test capability depends upon the Pulmonary Function Testing device being employed. Completed test information can be printed and handed to the physician for interpretation or data can be routed to the EMR (Electronic Medical Record). ComPAS2 software connects using USB-powered desktop pulmonary function testing devices for the purpose of creating, adding and recalling subjects and performing pulmonary function testing on those subjects to aid in the measuring of the effect of lung disease on pulmonary function.
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    K Number
    K042595
    Device Name
    SPIRO'AIR
    Manufacturer
    MORGAN SCIENTIFIC, INC.
    Date Cleared
    2005-05-04

    (223 days)

    Product Code
    BZG
    Regulation Number
    868.1840
    Why did this record match?
    Applicant Name (Manufacturer) :

    MORGAN SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SpiroAir PFT System is intended to operate with the ComPAS pulmonary function software. ComPAS uses flow and volume from the SpiroAir to display the flow and volume information and to generate reports. ComPAS utilizes gas analysis from the SpiroAir to display single breath diffusion data and to generate reports.
    Device Description
    Not Found
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    K Number
    K022636
    Device Name
    BODY BOX 5500
    Manufacturer
    MORGAN SCIENTIFIC, INC.
    Date Cleared
    2003-01-13

    (158 days)

    Product Code
    JEH
    Regulation Number
    868.1760
    Why did this record match?
    Applicant Name (Manufacturer) :

    MORGAN SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Body Box 5500 when used in conjunction with a computer and the ComPAS pulmonary function software is intended to perform plethysmography, diffusion and spirometry to provide pulmonary function testing in adult and pediatric patients.
    Device Description
    Not Found
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    K Number
    K021200
    Device Name
    COMPAS
    Manufacturer
    MORGAN SCIENTIFIC, INC.
    Date Cleared
    2002-10-18

    (185 days)

    Product Code
    BZG
    Regulation Number
    868.1840
    Why did this record match?
    Applicant Name (Manufacturer) :

    MORGAN SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ComPAS software is intended to operate with the ScreenStar pneumotachograph spirometer, Morgan Transflow Test PFT System and the Morgan Transfer Test Benchmark PFT System. ComPAS uses flow and volume from each of the devices to display the flow and volume information measured directly from patient effort. ComPAS also utilizes gas analyzer readings from the Transflow Test and Transfer Test Benchmark to display helium dilution lung volume data and single breath diffusion data measured directly from patient effort. This information is formatted for use in pulmonary function testing and reports.
    Device Description
    Not Found
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    K Number
    K013752
    Device Name
    COMPAS AS (COMPUTERIZED PULMONARY ANALYSIS SYSTEM)
    Manufacturer
    MORGAN SCIENTIFIC, INC.
    Date Cleared
    2002-01-30

    (78 days)

    Product Code
    BZG
    Regulation Number
    868.1840
    Why did this record match?
    Applicant Name (Manufacturer) :

    MORGAN SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ComPAS software is intended to operate with the ScreenStar pneumotachograph The Oomr AS sonward to intended to tpon the ScreenStar to display the flow and volume spiromotor: Gomi FD doo hy from patient effort. This information is formatted for use in pulmonary function testing and reports.
    Device Description
    ComPAS (computerized Pulmonary Analysis Sysem)
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