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510(k) Data Aggregation

    K Number
    K220893
    Device Name
    Strados Remote Electronic Stethoscope Platform (RESP)
    Manufacturer
    Strados Labs, Inc.
    Date Cleared
    2022-04-27

    (30 days)

    Product Code
    DSH
    Regulation Number
    870.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Strados Labs, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Strados Remote Electronic Stethoscope Platform (RESP) is a non-invasive battery-operated device, including a wearable component, intended to longitudinally acquire, record, and store lung sounds from adult patients in a healthcare or outpatient setting including transition from healthcare setting to outpatient care without interruption. The device stores the data for later playback, review, and analysis by a clinician and comparison with earlier data from the same patient.
    Device Description
    The Strados Remote Electronic Stethoscope Platform (RESP) is a non-invasive battery-operated device, including a wearable component, intended to longitudinally acquire, record, and store lung sounds from adult patients. The device stores the data for later playback, review, and analysis by a clinician and comparison with earlier data from the same patient. The Strados Remote Electronic Stethoscope Platform (RESP) is comprised of the Strados Wearable Device (SWD), Strados Charging Station (SCS) and external power supply, and Strados Patient Adhesive (SPA) used to adhere the SWD to the patient. The SWD is controlled by a mobile device running the Strados Mobile Application (SMA) via Bluetooth connection. The Strados Wearable Device (SWD) sits on the chest wall and passively records the patient's airway sounds, including but not limited to cough, wheeze, rhonchi, rales, crackles, coarse (bronchial) breath sounds, quiet breathing, and chest wall movement onto internal memory. The Strados Mobile App (SMA) on a smartphone allows playback of lung sounds from the wearable device in order for clinicians to listen to the patient's lung sounds. The device is used in a healthcare and outpatient setting including the home.
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    K Number
    K201077
    Device Name
    Strados Remote Electronic Stethoscope Platform (RESP)
    Manufacturer
    Strados Labs
    Date Cleared
    2020-12-20

    (242 days)

    Product Code
    DSH
    Regulation Number
    870.2800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Strados Labs

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RESP is a non-invasive battery-operated device, including a wearable component, intended to longitudinally acquire, record, and store lung sounds from adult patients in a healthcare setting. The device stores the data for later playback, review, and analysis by a clinician on a mobile app.
    Device Description
    The RESP is a non-invasive battery-operated device, including a wearable component, intended to longitudinally acquire, record, and store lung sounds from adult patients in a healthcare setting. The device stores the data for later playback, review, and analysis by a clinician on a mobile app. The Strados Remote Electronic Stethoscope Platform (RESP) is comprised of the Strados Wearable Device (SWD), Strados Charging Station (SCS) and external power supply, and Strados Patient Adhesive (SPA) used to adhere the SWD to the patient. The SWD is controlled by a mobile device running the Strados Mobile Application (SMA) via Bluetooth connection. The Strados Wearable Device (SWD) sits on the chest wall and passively records the patient's lung sounds. The Strados Mobile App (SMA) on a smartphone allows playback of lung sounds from the wearable device in order for clinicians to listen to the patient's lung sounds. The device is used in a healthcare setting.
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