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510(k) Data Aggregation

    K Number
    K053063
    Device Name
    PRO-FLOW MULTIPURPOSE CANNULA
    Manufacturer
    PRO-TECH SERVICES, INC.
    Date Cleared
    2005-12-13

    (42 days)

    Product Code
    CCK
    Regulation Number
    868.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRO-TECH SERVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pro-Flow MultiPurpose Cannula may be intended for use for simultaneous detection of respiratory airflow and sampling, or delivery, of gases, such as EtC02 or oxygen.
    Device Description
    Not Found
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    K Number
    K033402
    Device Name
    PORTABLE SLEEP DATA RECORDER (PSDR)
    Manufacturer
    PRO-TECH SERVICES, INC.
    Date Cleared
    2004-06-30

    (250 days)

    Product Code
    MNR
    Regulation Number
    868.2375
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRO-TECH SERVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PSDR system is a physiological recorder intended to display and to record for later playback of thoracic and abdominal respiratory effort, airflow, oxygen saturation, pulse rate, and a 0-1 volt DC signal (such as CPAP pressure) on the auxiliary input. The PSDR is designed to be used in a supervised (hospital/institutional) or unsupervised (home) environment.
    Device Description
    Portable Sleep Data Recorder
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    K Number
    K013905
    Device Name
    MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS
    Manufacturer
    PRO-TECH SERVICES, INC.
    Date Cleared
    2002-04-22

    (147 days)

    Product Code
    MNR
    Regulation Number
    868.2375
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRO-TECH SERVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantum-Synchrony Respiratory Effort System (modification EZ-1 System Respiratory Sensors) amplifier is intented for use with Pro-Tech G inchrony or the censure during steep directed ing, belancing, summing and an effort 5%
    Device Description
    Quantum-Synchrony Respiratory Effort System (modification EZ-1 System Respiratory Sensors)
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    K Number
    K982293
    Device Name
    PRESSURE TRANSDUCER AIRFLOW SENSOR
    Manufacturer
    PRO-TECH SERVICES, INC.
    Date Cleared
    1998-07-13

    (12 days)

    Product Code
    MNR
    Regulation Number
    868.2375
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRO-TECH SERVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pressure Transducer Airflow Sensor is intended for use in sleep disorder studies to detect respiratory airflow for recording onto a physiological recorder. It is battery-powered, using a single patient use, disposable nasal cannula with a .2 micron hydrophobic filter that attaches to the patient and connects into the input of the Pressure Transducer Airflow Sensor. The cannula cannot be adequately cleaned for re-use. The outputs of the device provide low-level electrical signals for input to a physiological recorder (EEG, etc.),
    Device Description
    The Pressure Transducer Airlow Sensor is a small interface device which converts low levels of air pressure to corresponding low levels of voltage which can be recorded on any physiological recorder intended to record low-level electrical signals. There is one pressure, and one set of electrical outputs representing the electrical equivalent of the pressure. These electrical outputs are: the active or positive output and the reference or negative output. This device uses a disposable nasal cannula that attaches to the patient and connects to the pressure input. The electrical outputs connect to the corresponding AC-coupled inputs of the system's labeled INT O' : The electined outpote connels of an electrode jack box. The output jack on patient of the storing the modular 4-pin jack. Electrical connections are made with 1.5mm "safety" connectors. The device consists of a two-part plastic enclosure measuring approximately 7cm(W) x 12.5cm(L) x 2.5cm(H). The material is Oycolac ABS GSM, color light gray. It is battery-powered with one standard 9V alkaline cell. The estimated battery life is 320 hours (40 - eight hour uses), with an on-off switch provided to conserve battery life when not in use. The switch will also indicate a "battery test" that lights an LED indicating at least 8 hours of battery life remaining. Batteries can be replaced by removing the battery cover, removing the battery and inserting a new one in the orientation shown in the battery compartment of the unit.
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    K Number
    K972515
    Device Name
    SENSOR AMPLIFIER
    Manufacturer
    PRO-TECH SERVICES, INC.
    Date Cleared
    1997-10-02

    (91 days)

    Product Code
    GWL, 84G
    Regulation Number
    882.1835
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRO-TECH SERVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TO PROVIDE AN AMPLIFYING INTERFACE BETWEEN PRO-TECH SENSOR OUTPUT AND CUSTOMER RECORDING EQUIPMENT IN PUT. THE SENSOR ANPLIFIER IS TO BE USED WITH SUBTETS (CHILDRING E ADVES) WHERE THE RECORDING EQUIPMENT REQUIRES A HIGHER INPUT SIGNAL , THE DOVE IS INFENDED FOR SLOUD LABS.
    Device Description
    Not Found
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    K Number
    K960851
    Device Name
    THERMISTOR CANNULA STYLE,SINGLE ELEMENT,ADAM SHELL THERMISTOR AIRFLOW SENSOR
    Manufacturer
    PRO-TECH SERVICES, INC.
    Date Cleared
    1996-09-17

    (200 days)

    Product Code
    BZQ
    Regulation Number
    868.2375
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRO-TECH SERVICES, INC.

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