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510(k) Data Aggregation

    K Number
    K220196
    Device Name
    Steth IO Spot
    Manufacturer
    Date Cleared
    2022-03-24

    (59 days)

    Product Code
    Regulation Number
    870.1875
    Why did this record match?
    Applicant Name (Manufacturer) :

    StratoScientific

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Steth IO Spot is an electronic stethoscope that enables amplification, filtering, and transmission of auscultation sound data, whereby a clinician at one location on network can listen to the auscultation sounds of a patient on site or at a different location on the network. Steth IO Spot is intended for use on individuals undergoing physical examination. The Steth IO Spot is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is not intended for self-diagnosis or emergency use. OTC use: Steth IO Spot can be used by a patient to be examined during a video call and to submit a non-emergent-examination for review by their healthcare provider. Rx-only use: Steth IO Spot may be prescribed by a licensed medical provider to monitor medical conditions that require the use of a stethoscope.
    Device Description
    The Steth IO Spot is an acoustic device with an integrated microphone that collects biological sounds. Steth IO Spot attaches to the lightning port/USB-Type C (Universal Serial Bus Type C) port of the smartphone and can be utilized to auscultate patients during physical examination. The sound is then analyzed by the Steth IO Spot software telemedicine application (app) installed on the smartphone. This analysis enables a healthcare provider to identify sounds and from targeted areas of interest that may be present. A web portal (i.e., the Steth IO Portal) may also be used to access recorded patient data and to hold telemedicine calls. The Steth IO Spot device has two main components: - Steth IO Spot device: The Steth IO Spot device is capable of transmitting your heart, lung or other biological sounds to the mobile device. This device needs to be connected to the smartphone's lightning port/USB-Type C port. - Steth IO Spot Software (Telemedicine App): The Steth IO smartphone application software performs real-time analysis to hear the sounds using headphones. The app is available for download from a designated software repository. A chest piece, consisting of a bell and diaphragm, and an integrated microphone is placed on the patient and the sound is transmitted to a smartphone via lightning port/USB-C port. The device is capable of recording sound data, allowing the patient-user at one location to share audio data with their healthcare provider on site or at a different location on the network.
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    K Number
    K160016
    Device Name
    Steth IO
    Date Cleared
    2016-07-15

    (192 days)

    Product Code
    Regulation Number
    870.1875
    Why did this record match?
    Applicant Name (Manufacturer) :

    STRATOSCIENTIFIC, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The StratoScientific Steth IO Stethoscope and Phonocardiogram Model 1.0 is intended for medical diagnostic purposes only. It may be used for the detection of sounds from the heart, and lungs with the use of selective frequency ranges. It has been tested for use on adults undergoing a physical assessment.
    Device Description
    Steth IO is an acoustic device that is used in conjunction with a smartphone to collect heart and lung sounds. Steth IO attaches to the back of the smartphone and contains an acoustic wave guide that channels sound from the Steth IO chest piece to the smartphone's microphone, while also acting as a protective covering for the phone. The Steth IO smartphone application software performs real-time analysis so the user can hear the sounds using headphones, and visualize the sound using the on-screen phonocardiogram. The device is capable of recording sound and phonocardiogram data, allowing healthcare providers to capture biological sounds and send the data to other healthcare providers or for review at a later time. Steth IO is intended for use as a diagnostic aid, enabling the healthcare provider to identify sounds and any abnormalities that may be present.
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