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510(k) Data Aggregation

    K Number
    K150515
    Device Name
    IQSense Flow Sensor Mouthpiece
    Manufacturer
    SDI DIAGNOSTICS, INC.
    Date Cleared
    2016-01-12

    (316 days)

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

    SDI DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IQSense Flow Sensor Mouthpiece is intended to be used as a disposable pneumotach mouthpiece for the Midmark (formerly Brentwood) IQspiro Digital Spirometer.
    Device Description
    Not Found
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    K Number
    K092813
    Device Name
    ASTRASONIC SPIROMETER, MODEL 29-8000
    Manufacturer
    SDI DIAGNOSTICS, INC.
    Date Cleared
    2010-07-16

    (305 days)

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

    SDI DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SDI AstraSonic Spirometer is a freestanding laboratory instrument for performing basic lung function tests in adults and children over the age of four years. It is intended to be used by physicians or professional medical personnel for testing in physicians' offices, industrial medical and hospital settings.
    Device Description
    The AstraSonic Diagnostic Spirometer is a hand-held portable diagnostic spirometer for the measurement of patient breath flow and volume. The device uses an ultrasonic transducer that measures flow. Algorithms are used to determine values based on this flow measurement. Tabular and graphical data are displayed on the spirometer LCD display.
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    K Number
    K061571
    Device Name
    ASTRA 300
    Manufacturer
    SDI DIAGNOSTICS, INC.
    Date Cleared
    2007-01-31

    (239 days)

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

    SDI DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SDI Astra 300 Spirometer is a freestanding laboratory instrument for performing basic lung function tests and oximetry in people of all ages. It is intended to be used by physicians or professional medical personnel for testing in any setting.
    Device Description
    The ASTRA 300 Diagnostic Spirometer is a hand-held portable diagnostic spirometer for the measurement of patient breath flow and volume. The device uses a turbine transducer that measures flow via infrared interruption. Algorithms are used to determine values based on this flow measurement. Tabular and graphical data are displayed on the spirometer LCD display. With the optional Pulse Oximeter module, the specific patient parameters oxygen saturation in the blood (SpO2) and pulse rate, both relating to the patient's pulmonary condition, may be measured and displayed.
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    K Number
    K062913
    Device Name
    ASTRAGUARD PULMONARY FUNCTION FILTER
    Manufacturer
    SDI DIAGNOSTICS, INC.
    Date Cleared
    2007-01-26

    (121 days)

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

    SDI DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AstraGuard Pulmonary Function Filter is intended for use in reducing possible bacterial and/or viral cross contamination of spirometers and pulmonary testing instruments, associated valves and hoses, from aerosols and particulates, which may be present in a patient's exhaled gas. The device is indicated for diagnostic applications.
    Device Description
    The SDI AstraGuard Pulmonary Function Filter is an electrostatic polypropylene medium enclosed in a molded polystyrene shell. The highly efficient medium is ultrasonically welded to the shell body.
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    K Number
    K033939
    Device Name
    FLOSENSE II, MODEL 29-8040
    Manufacturer
    SDI DIAGNOSTICS, INC.
    Date Cleared
    2004-01-30

    (46 days)

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

    SDI DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Flosense II is intended to be used as a disposable pneumotach for the Puritan-Bennett Renaissance II Spirometers which currently use the Puritan Bennett FSII Flow Sensor.
    Device Description
    Not Found
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    K Number
    K031643
    Device Name
    SPIROTEL, MODEL 29-1020
    Manufacturer
    SDI DIAGNOSTICS, INC.
    Date Cleared
    2003-12-09

    (196 days)

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

    SDI DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The spirotel spirometer is intended to be used by a patient under indications For 500. The opirator epiratory therapist to test lung function in people of all the matraction of a priyation of a single-patient device only and can be used in any setting - home, factory, hospital or physician's office.
    Device Description
    Not Found
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    K Number
    K013812
    Device Name
    SPIROLAB II, MODEL 29
    Manufacturer
    SDI DIAGNOSTICS, INC.
    Date Cleared
    2002-02-11

    (88 days)

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

    SDI DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Spirolab II Spirometer is intended to be used by a physician or respiratory therapist or trained technician to measure lung function in patients of all ages. It can be used in any setting, home, factory, hospital or physician's office.
    Device Description
    Not Found
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    K Number
    K011470
    Device Name
    SDI SB OFFICE, MODEL 29-
    Manufacturer
    SDI DIAGNOSTICS, INC.
    Date Cleared
    2001-10-12

    (151 days)

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

    SDI DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K990962
    Device Name
    FLOSENSE, MODEL 29-8010
    Manufacturer
    SDI DIAGNOSTICS, INC.
    Date Cleared
    2000-01-07

    (291 days)

    Product Code
    JAX
    Regulation Number
    868.2550
    Why did this record match?
    Applicant Name (Manufacturer) :

    SDI DIAGNOSTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Flosense is intended to be used as a disposable pneumotach for Puritan-Bennett spirometers which currently use the Puritan Bennett FS200 Flow Sensor.
    Device Description
    Not Found
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