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510(k) Data Aggregation
K Number
K200862Device Name
Feelix Stethoscope
Manufacturer
Date Cleared
2020-09-14
(166 days)
Product Code
Regulation Number
870.1875Why 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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