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510(k) Data Aggregation
K Number
K212709Device Name
VoqX Electronic Stethoscope
Manufacturer
Date Cleared
2022-03-15
(201 days)
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
Sanolla Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The VoqX Electronic Stethoscope is intended for medical diagnostic purposes only. It may be used for the detection and amplification of sounds from the heart, lungs, arteries, veins, and other internal organs with the use of a selective frequency and with an integrated graphics display to show amplified heart sounds as phonocardiograms. It can be used on any person undergoing a physical assessment.
Device Description
The VoqX Electronic Stethoscope is intended for medical diagnostic purposes. It may be used for the detection and amplification of sounds from the heart, lungs, arteries, veins, and other internal organs with the use of a selective frequency and with an integrated graphics display to show amplified heart sounds as phonocardiograms.
The VoqX Electronic Stethoscope is comprised of two parts: Back Unit (head piece) and Front Unit (chest piece).
The device has 3 modes of operation: General - emphasizes sounds from 20 to 2000Hz, Heart emphasizes sounds from 20 to 200Hz and Lungs - emphasizes sounds from 100 to 500Hz. In addition, the VoqX Electronic Stethoscope incorporates a software feature that displays sounds as a "Sound Signature". The "Sound Signature" algorithm generates intensity image based on the spectrogram of the output audio data. The device is supplied with an AC/DC power supply adapter and a charging cable.
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