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510(k) Data Aggregation

    K Number
    K240901
    Device Name
    Stethophone
    Manufacturer
    Sparrow Acoustics Inc.
    Date Cleared
    2024-09-19

    (170 days)

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

    Sparrow Acoustics Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Stethophone Pro is an electronic stethoscope that enables detection, filtering, and transmission of auscultation sound data (heart and lungs). Stethophone Pro is intended to provide decision support to clinicians in their evaluation of patients heart sounds. The software analyzes heart sounds and phonocardiograms and can automatically detect murmurs that may be present, sound timing and character, including S1, S2, and the absence of a heart murmur. Stethophone Pro is not intended to be used as a sole means of diagnosis and is for use in environments where health care is provided by clinicians. The interpretations offered by the software are meant only to provide decision support to the clinician, who may use the result in conjunction with their own evaluation and clinical judgment. The interpretations are not diagnoses. Stethophone Pro is intended for use on adult patients.
    Device Description
    Stethophone Pro is an electronic stethoscope software application that operates on smartphones. Stethophone Pro is designed for use by healthcare professionals or on the order of healthcare professionals. Stethophone Pro enables the capture and amplification of chest sounds for real-time or recorded listening. Cloud storage with sound record sending capabilities, filtering for selected frequency ranges, and visualization all assist with sound analysis. Stethophone Pro is designed to assist healthcare professionals in both hearing and visualizing heart and lung sounds during a physical examination of a patient and in storing recorded sounds in the cloud for later analysis. It also enables home users to record and send chest sounds to their physicians. Stethophone Pro can be used for the assessment of chest sounds of adult patients in clinical and non-clinical environments. Assessment is performed by healthcare professionals, while sound capturing can be performed by both healthcare professionals and home users. Stethophone Pro performs basic analysis of heart sounds allowing to detect the presence of murmurs, locate heartbeats on the timeline (S1/S2), and calculate timing between them. Key product features: - Capturing chest sounds using the smartphone microphone: - Real-time listening to chest sounds, - Recording of chest sounds, - Sending examinations to specialists for assessment, - Two modes of sound visualization: oscillogram and spectrogram, - Detecting murmurs, timing for S1 and S2 sounds, and calculating heart rate, - Selecting from three audio filters for listening: - Bell: Traditional filter used in stethoscopes for low frequency sounds, - Diaphragm: Traditional filter used for higher frequency sounds of heart and lungs, and - Starling: Filter for listening to the full frequency of chest sounds. Collectively, these features enable users to acquire heart sounds and receive basic reporting, so as enable healthcare professionals to examine and monitor patients on site and remotely, seek out second opinions from specialists, and use the device in a telemedicine context.
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    K Number
    K231551
    Device Name
    Stethophone
    Manufacturer
    Sparrow Acoustics Inc.
    Date Cleared
    2023-10-12

    (135 days)

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

    Sparrow Acoustics Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Stethophone is an electronic stethoscope that enables detection, amplification, filtering, and transmission of auscultation sound data (heart and lungs), whereby a clinician at one location can listen to the auscultation sounds of a patient acquired on site or at a different location. Stethophone is intended for use on adult patients. Stethophone is intended to be used by professional or lay users in a clinical or nonclinical environment. Stethophone is not intended for self-diagnosis.
    Device Description
    Stethophone is an electronic stethoscope software application that operates on smartphones. Stethophone is designed for use by both healthcare professionals and home users. Stethophone enables the capture and amplification of chest sounds for real-time or recorded listening. Cloud storage with sound record sending capabilities, filtering for selected frequency ranges, and visualization all assist with sound analysis. Stethophone is designed to assist healthcare providers both in hearing and visualizing heart and lung sounds during a physical examination of a patient and in storing recorded sounds in cloud for later analysis. It also enables home users to record and send chest sounds to their physicians. Stethophone is a decision support device used for the assessment of chest sounds of adult patients in clinical and non-clinical environments. Assessment is performed by healthcare providers, while sound capturing can be performed by both healthcare providers and home users. Key product features: - Capturing chest sounds using the smartphone microphone: - Real-time listening to chest sounds, - Recording of chest sounds, - Sending examinations to specialists for assessment - Two modes of sound visualization: oscillogram and spectrogram, and - Selection of three audio filters for listening: - Bell: Traditional filter used for low frequency sounds, - Diaphragm: Traditional filter used for higher frequency sounds of heart and lungs, and - Starling: Filter for listening to the full frequency of chest sounds. Collectively, these features enable a healthcare professional to examine and monitor patients, seek out second opinions from specialists, and use the device in a telemedicine context.
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    K Number
    K222871
    Device Name
    Stethophone v1
    Manufacturer
    Sparrow Acoustics Inc.
    Date Cleared
    2023-03-29

    (188 days)

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

    Sparrow Acoustics Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Stethophone v1 is intended for medical diagnostic purposes only. It may be used for detection and amplification of sounds from the heart and lungs with the use of selective frequency ranges. It can be used on adults undergoing physical assessment.
    Device Description
    Stethophone v1 is an electronic stethoscope software application that operates on smartphones. Stethophone v1 allows for the capture and amplification of chest sounds that are listened in real-time or recorded, cloud storage of sound records, sound filtering for selected frequency ranges, and visualization to assist in sound analysis. Stethophone v1 is designed to assist healthcare providers to hear and visualize heart and lung sounds during a physical examination of a patient as well as storing recorded sounds for later analysis. Stethophone v1 is a decision support device used for the assessment of chest sounds of adult patients in clinical and non-clinical environments. Key product features: - Acquiring sound through the smartphone microphone - Real-time listening of chest sounds - Recording of chest sounds - Two modes of sound visualization: oscillogram and spectrogram - Selecting among three sound filters for listening: - Bell: Classic filter used for low frequency sounds - Diaphraqm: Classic filter used for higher frequency sounds of heart and lungs - Starling: Filter for listening to the full frequency of chest sounds
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