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510(k) Data Aggregation

    K Number
    K231733
    Device Name
    Neteera 130H-Plus Vital Sign Monitoring Sensor
    Manufacturer
    Neteera Technologies Ltd.
    Date Cleared
    2024-02-09

    (241 days)

    Product Code
    DRT, BZQ
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Neteera Technologies Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neteera 130H-Plus device is intended for spot and continuous measurement of heart rate and respiration rate in adult patients (in healthcare facilities and home monitoring) and inform on bed exit. The indications provided are to be used by health care professionals and are intended to be reviewed by clinicians to inform patient care. The Neteera device is not intended to be used as an alarm system for potentially acute life-threatening situations in which medical intervention is necessary (e.g., ICU).
    Device Description
    Neteera 130H-Plus device is a modification of the predicate device Neteera 130H (K212143). It is a contact-free vital-signs monitor based on a high frequency (122.25-123 GHz) micro-radar on-chip and algorithm, capable of detecting Respiration Rate (RR) and Heart Rate (HR) during rest or subject's mild body movement, with the additional capability of identifying and notifying on bed exit. Neteera's micro- radar-based solution enables remote measurement, in real-time, in a non-invasive and contact-free manner. The system works by measuring only the ballistocardiograph micro-movements of of the skin (BCG) through nonmetallic materials such as furniture and clothing at a high resolution, and it has several different mounting options and measuring ranges.
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    K Number
    K212143
    Device Name
    Neteera 130H/131H Vital Sign Monitoring Sensor
    Manufacturer
    Neteera Technologies Ltd.
    Date Cleared
    2022-09-28

    (446 days)

    Product Code
    DRT, BZQ
    Regulation Number
    870.2300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Neteera Technologies Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neteera 130H/131H device is intended for spot and continuous measurement of heart rate and respiration rate in adult patients (in healthcare facilities and home monitoring). The indications provided are to be used by health care professionals and are intended to be reviewed by clinicians to inform patient care. The Neteera device is not intended to be used as an alarm system for potentially acute life-threatening situations in which medical intervention is necessary (e.g., ICU).
    Device Description
    Neteera 130H/131H device is a contact-free vital-signs monitor based on a high frequency (122.25-123 GHz) micro-radar on-chip and algorithm, capable of detecting a variety of parameters: Respiration Rate (RR), Heart Rate (HR), during rest or subject's mild body movement. Neteera's micro radar-based solution enables measuring the micro-motions of the skin (BCG-Ballistocardiograph) remotely, in a real-time, non-invasive, and non-contact manner, through non-metallic materials such as furniture and clothing at a high resolution.
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