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510(k) Data Aggregation

    K Number
    K123896
    Device Name
    CCS-200 SPIROMETER
    Manufacturer
    BENSON MEDICAL INSTRUMENTS CO.
    Date Cleared
    2013-09-10

    (266 days)

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

    BENSON MEDICAL INSTRUMENTS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CCS-200 Spirometer is intended for prescription use only to conduct diagnostic spirometry testing of adults and pediatric patients who are at least 16 years old, in general practice, specialty physician, industrial, and hospital settings.
    Device Description
    The CCS-200 Spirometer System consists of Microsoft Windows based personal computer (PC) software (BUL) and the CCS-200 flow sensing instrument. The BUL software is installed on a desktop or laptop PC to which the CCS-200 flow sensing instrument is connected. In order to conduct spirometry testing the CCS-200 flow sensing instrument is used in combination with a single-use disposable airway tube with integrated mouthpiece (U-tube). The flow sensing instrument measures transit time of ultrasound pulses through the air in the U-tube to determine flow velocity and volume. The collected data are transferred to the PC for pulmonary function evaluation and data management. The results of the testing are stored in a database. Reports can be displayed or printed.
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    K Number
    K982441
    Device Name
    CCA-220
    Manufacturer
    BENSON MEDICAL INSTRUMENTS CO.
    Date Cleared
    1998-10-09

    (87 days)

    Product Code
    EWO
    Regulation Number
    874.1050
    Why did this record match?
    Applicant Name (Manufacturer) :

    BENSON MEDICAL INSTRUMENTS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CCA-220 Audiometer is an air-conduction audiometer designed to provide automatic hearing testing. A series of tones is presented by the CCA-220 through a Telephonics TDH-39 headset. The test subject then presses a hand switch to indicate to the CCA-200 that the tone has been heard. The CCA-220 proceeds with the hearing testing, and records the subject's responses. The resultant test data are available to print on an integral printer or to store in the CCA-220's hard drive.
    Device Description
    The CCA-220 has an integral computer which provides all of the capabilities of the instrument. The instrument's display panel shows the setup and control screens that are used to perform. the test functions. The instrument is based on an integral PC compatible computer with a Pentitura processor, running the operating system of Microsoft Windows 95. Control of the CCA-220 is handled by selecting the desired test elements on the touch screen monitor. The instrument also incorporates an internal printer for printing test results. The CCA-220 has a range of options for both computer interfacing and automatic testing, such as error detection and multilingual voice instruction. These options are selected using the setup screen on the touch-screen monitor.
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    K Number
    K981439
    Device Name
    CCA-200
    Manufacturer
    BENSON MEDICAL INSTRUMENTS CO.
    Date Cleared
    1998-06-15

    (55 days)

    Product Code
    EWO
    Regulation Number
    874.1050
    Why did this record match?
    Applicant Name (Manufacturer) :

    BENSON MEDICAL INSTRUMENTS CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CCA-200 Computer Controlled Audiometer is an air conduction audiometer designed to provide automatic hearing testing. A series of tones is presented by the CCA-200 through a TDH-39 headset to the test subject. The test subject then presses a hand switch to indicate Lo the CCA-200 that the tone bas been heard. The CCA-200 proceeds with the hearing test using the Modified Hughson-Westlake method of hearing testing, and records the subject's responses, The resultant data are available to print on an external printer connected to the control computer or to store in the computer. The CCA-200 can perform its function only on command from a control computer. The computer monitor displays the setup and control screens that are used to perform the Lest functions. An IRM compatible computer with a 486DX2-50 or proceessor, running Windows 95 or Windows NT, is required. Control of the CCA-200 is handled through the RS232 serial port. The computer is not included with the CCA-200. The CCA-200 is designed for use in test environments where multiple automatic hearing tests are controlled from a single computer. The CCA-200 has a range of options for both computer interfacing and automatic testing, such as multilingual voice instructions. These options are selected using a setup screen on the computer.
    Device Description
    The CCA-200 Computer Controlled Audiometer is an air conduction audiometer designed to provide automatic hearing testing. A series of tones is presented by the CCA-200 through a TDH-39 headset to the test subject. The test subject then presses a hand switch to indicate Lo the CCA-200 that the tone bas been heard. The CCA-200 proceeds with the hearing test using the Modified Hughson-Westlake method of hearing testing, and records the subject's responses, The resultant data are available to print on an external printer connected to the control computer or to store in the computer. The CCA-200 can perform its function only on command from a control computer. The computer monitor displays the setup and control screens that are used to perform the Lest functions. An IRM compatible computer with a 486DX2-50 or proceessor, running Windows 95 or Windows NT, is required. Control of the CCA-200 is handled through the RS232 serial port. The computer is not included with the CCA-200. The CCA-200 is designed for use in test environments where multiple automatic hearing tests are controlled from a single computer. The CCA-200 has a range of options for both computer interfacing and automatic testing, such as multilingual voice instructions. These options are selected using a setup screen on the computer.
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    K Number
    K963681
    Device Name
    CCA-100 (MODIFIED)
    Manufacturer
    BENSON MEDICAL INSTRUMENTS CO.
    Date Cleared
    1996-10-08

    (89 days)

    Product Code
    EWO
    Regulation Number
    874.1050
    Why did this record match?
    Applicant Name (Manufacturer) :

    BENSON MEDICAL INSTRUMENTS CO.

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