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510(k) Data Aggregation

    K Number
    K242290
    Device Name
    DormoTech NLab
    Manufacturer
    DormoTech Medical LTD
    Date Cleared
    2025-01-08

    (159 days)

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

    DormoTech Medical LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DormoTech Nlab is a physiological data recorder intended to collect and record data from multiple physiological channels for use by clinical software used in polysomnography and sleep disorder studies. It is intended for use by or on the order of a physician. It is intended for use on patients greater than 6 years of age in a supervised (hospital) or unsupervised (home) environments.
    Device Description
    The DormoTech Nlab is a physiological data recorder intended to collect and record data from multiple physiological channels for use by clinical software used in polysomnography and sleep disorder studies. It is intended for use by or on the order of a physician and is intended for use on patients greater than 6 years of age in a supervised (hospital) or unsupervised (home) environment. It consists of: The Head Unit The head unit acquires electric signals indicative of EEG and eye movement located in the upper part of the unit (on the patient's forehead). Plethysmograph for Heart rate and SpO2 measurements, and head relative position to body position are also measured using accelerometer sensors located in the upper part of the unit. The middle part of the unit is located below the mouth, it contains 2 nasal (one in each nostril) and 1 oral airflow sensors (thermistors), 1 EMG sensor, along with a snoring sensor. The Body Unit The body unit is made of 2 belts, the upper belt sits on the lower belt sits on the stomach of the patient. Both belts contain respiratory effort and accelerometer sensors, in addition, the upper belt contains an accelerometer to measure body position. The ExG Unit The ExG unit is put on using an adhesive sticker on the leg/arm/chest (either leg/arm is ok). It consists of 3 electrodes that acquire leg/arm/chest ExG signal. The Central Unit The head, chest and ExG units communicate with the central unit via Bluetooth, the wearable units send the measured data to the central unit receives the data, stores it within an internal flash drive and then transmits the data via Wi-Fi to online servers for further diagnosis. The central unit is located in the test room (up to 10 meters from the patient). The central unit has no contact with the patient. To ensure device reusability between sessions or patients, sections of the head unit have been designed to be detachable or with barriers between the sensor and patient's skin to stop direct contact. Specifically, the head unit incorporates (1) a detachable nasal and oral airflow section to allow for replacement of the section between each use of the device, (2) a removable barrier over the plethysmograph recorder to create a separation between the patient's skin and the recording device which is replaced between each use of the device and (3) a detachable textile on the inner side of the head unit (i.e., the side in direct contact with the patient's skin) to allow for replacement between each use of the device.
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    K Number
    K230148
    Device Name
    Vlab
    Manufacturer
    DormoTech Medical Ltd.
    Date Cleared
    2023-10-11

    (265 days)

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

    DormoTech Medical Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DormoTech Vlab is a physiological data recorder intended to collect and record data from multiple physiological channels for use by clinical software used in polysomnography and sleep disorder studies. It is intended for use by or on the order of a physician is intended for use on adults in a supervised (hospital) or unsupervised (home) environment.
    Device Description
    The DormoTech Vlab is a physiological data recorder intended to collect and record data from multiple physiological channels for use by clinical software used in polysomnography and sleep disorder studies. It consists of: The Head Unit, The Body Unit, and The Central Unit.
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