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510(k) Data Aggregation
K Number
K220466Device Name
ibiomedi Electronic Stethoscope ES-2020
Manufacturer
Date Cleared
2022-11-03
(259 days)
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
Sound Land Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ibiomedi Electronic Stethoscope ES-2020 is used to detect sound from the heart, arteries, veins, breathing sounds from the anterior/lateral chest and throat sounds in the neck. The chest piece is designed for children who are over two years old, teenagers and adults. It can be applied to any body type and can only be used for the purpose of medical diagnosis in clinics or hospitals.
Device Description
The ibiomedi Electronic Stethoscope ES-2020 detects sounds from the heart, arteries, veins, breathing sounds from the anterior/posterior/lateral chest and throat sounds in the neck of patients. The sounds are transmitted to the user's ears through accessories such as earphones.
User interface includes A: Power button, frequency response mode button, volume button B: Power indicator, wireless transmission indicator, frequency response mode indicator, volume indicator.
Turn on the ibiomedi Electronic Stethoscope ES-2020 and connect to the wireless device via Bluetooth to transmit and store sounds. When the ibiomedi Electronic Stethoscope ES-2020 and the connected wireless device have walls, human bodies and other barriers, the effective range of Bluetooth transmission will be affected. It is recommended to reduce the distance between the ibiomedi Electronic Stethoscope ES-2020 and the connected wireless device to improve Bluetooth connection.Power to the device is provided by two AAA 1.5V batteries.
The associated accessories include.
- Small chest piece: For children with diaphragm. .
- Large chest piece: For adult with diaphragm.
- Audio line: For connecting external speakers.
- . 1MORE Earphones: For medical personnel to connect the ibiomedi Electronic Stethoscope ES-2020.
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