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510(k) Data Aggregation

    K Number
    K200862
    Device Name
    Feelix Stethoscope
    Manufacturer
    Date Cleared
    2020-09-14

    (166 days)

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

    Sonavi Labs, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Feelix Stethoscope is intended for the detection, amplification and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. It can be used on any person undergoing a physical examination.
    Device Description
    Sonavi Labs, in collaboration with Johns Hopkins University, has developed a next generation stethoscope with pristine digital audio to help clinicians and healthcare workers detect, amplify, and record sounds during physical examination. The Feelix Stethoscope (Feelix) re-engineers the classic stethoscope and offers three major improvements: (1) more uniform sensitivity over its entire face so that sound quality is less dependent on placement on the body (2) leading noise suppression and sound volume control, and (3) onboard real-time algorithms so the device can operate as a stand-alone rather than requiring connection to a computer.
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