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510(k) Data Aggregation

    K Number
    K983572
    Device Name
    SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500
    Manufacturer
    HEALTHDYNE TECHNOLOGIES, INC.
    Date Cleared
    1999-03-19

    (157 days)

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

    HEALTHDYNE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Simon™ is a multichannel recording system designed to record and store physiological signals acquired from adult and pediatric patients during sleep. The portable design of the device facilitates its use in any clinical setting or in the home environment. Physiological signals are acquired via transducers attached to the patient and directly connected to the recorder. Additionally, a modem may be used to connect to the Host PC during acquisition, to interface with a Respironics CPAP or BiPAP device for titration or to download the data post acquisition. Once downloaded, the recorded data can be scored for physiological events using the associated Simon™ HOST Software. The clinician can review, validate, edit and print scored data. The software allows the user to configure / customize all reports to best meet individual needs.
    Device Description
    Simon™ is a multichannel recording system, which may be used for adult or pediatric patients in a variety of settings. The system is comprised of the Simon Recorder, Host Software, auxiliary CPAP / BiPAP devices (as applicable), computer equipment (CPU and monitor) and various accessories (modem, etc.). The recorder is small, lightweight and may be worn while the patient sleeps. The recorder collects physiologic signals from sensors attached to the patient. This eight-channel system records Nasal Flow or Pressure, Body Position, Snoring Sounds, Oximetry, Respiration via Chest Effort, Respiration via Abdominal Effort, Actigraphy, Pressure and Flow from auxiliary Respironics CPAP / BiPAP devices. The Simon™ Host Software is a Windows-based application, which facilitates remote titration of CPAP / BiPAP settings via modem, as well as download of recorded data onto a personal computer. Once downloaded, the Host software scores the recorded data for physiological events per user-defined parameters. The software allows user validation/editing of all events, and provides reporting capabilities that are fully user-configurable.
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    K Number
    K974453
    Device Name
    NASAL INTERFACE MODEL 7910
    Manufacturer
    HEALTHDYNE TECHNOLOGIES, INC.
    Date Cleared
    1998-08-04

    (252 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEALTHDYNE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nasal Interface is intended for use with nasal CPAP and bilevel devices for the treatment of adult patients with Obstructive Sleep Apnea. The Nasal Interface may be used in the home, hospital, nursing home, sub-acute care center or other location where nasal CPAP or bilevel therapy is applied. The Nasal Interface will facilitate nasal CPAP or bilevel therapy via a silicone seal which makes contact solely with the patient's nose on the external aspects of the nares. This device is further supported by padded protuberances, which rest on the patient's cheeks below the zygomatic processes. The device is held in place with headgear, which extends back from the nasal interface around the back and top of the patient's head.
    Device Description
    Nasal Interface
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    K Number
    K974879
    Device Name
    MODEL 7410 VOYAGER
    Manufacturer
    HEALTHDYNE TECHNOLOGIES, INC.
    Date Cleared
    1998-06-29

    (181 days)

    Product Code
    BZD, MAR
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEALTHDYNE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Model 7410 series CPAP system is a device that is intended to provide continuous positive airway pressure to adults who experience obstructive sleep apnea (OSA). The device will automatically adjust and maintain airway pressure based on the continuing needs of the patient. The device may be used in either the home or hospital environment.
    Device Description
    Model 7410 Series CPAP System
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    K Number
    K972614
    Device Name
    TWISTER OXYGEN CONCENTRATOR MODEL 600, TWISTER OXYGEN CONCENTRATOR W/OPI MODEL 605
    Manufacturer
    HEALTHDYNE TECHNOLOGIES, INC.
    Date Cleared
    1998-01-20

    (190 days)

    Product Code
    CAW, DEC
    Regulation Number
    868.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEALTHDYNE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Twister Oxygen Concentrator is intended to provide oxygen to persons requiring low flow oxygen therapy. This device is not intended to be life supporting nor life sustaining.
    Device Description
    The Twister produces concentrated oxygen from room air for delivery to a patient requiring low flow oxygen therapy. The oxygen from the air is concentrated using a molecular sieve and a pressure swing adsorption process.
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    K Number
    K971867
    Device Name
    ALICE 4R SYSTEM
    Manufacturer
    HEALTHDYNE TECHNOLOGIES, INC.
    Date Cleared
    1997-08-13

    (85 days)

    Product Code
    OLV
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEALTHDYNE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Alice® 4 System is a polysomnographic system that is intended to record, display, and print EEG and other physiological information to clinicians/physicians. The device will be used in hospitals, institutions, sleep centers or clinics, or other test environments where adult or infant patients require the documentation of various sleep or other physiological disorders.
    Device Description
    polysomnographic system that is intended to record, display, and print EEG and other physiological information
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    K Number
    K971545
    Device Name
    PROTEGE LIQUID OXYGEN SYSTEM
    Manufacturer
    HEALTHDYNE TECHNOLOGIES, INC.
    Date Cleared
    1997-07-25

    (88 days)

    Product Code
    BYJ
    Regulation Number
    868.5655
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEALTHDYNE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use for the liquid oxygen system is to provide supplementury oxygen at a prescribed flow rate to patients with lung disorders such as COPD (Chronic Obstructive Pulmonary Disease) or other conditions as prescribed by a physician.
    Device Description
    Portable Liquid Oxygen System BYJ
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    K Number
    K970173
    Device Name
    MODEL 1700 TRANQUILITY BILEVEL SYSTEM
    Manufacturer
    HEALTHDYNE TECHNOLOGIES, INC.
    Date Cleared
    1997-04-16

    (90 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEALTHDYNE TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K962517
    Device Name
    MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV
    Manufacturer
    HEALTHDYNE TECHNOLOGIES, INC.
    Date Cleared
    1997-02-20

    (238 days)

    Product Code
    MNS
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    HEALTHDYNE TECHNOLOGIES, INC.

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