Cardiart Electronic Stethoscope Model DS101 Omni-Steth
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K182196 FDA 510(k)
- FDA Product Code
- DQD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1875 FDA 510(k)
- Regulation Number
- 870.1875 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Cardiart Electronic Stethoscope Model DS101 Omni-Steth is an electronic stethoscope designed for the detection, amplification, and recording of sounds from internal organs. It captures acoustic data from the heart, lungs, chest, abdomen, neck, limbs, arteries, and veins using selective frequency ranges.
This device features a Bluetooth Class 2 wireless data link and is suitable for use with child, adolescent, and adult patients. It has received FDA 510K authorization under regulation number 870.1875.
Frequently asked questions
What is the primary function of the Cardiart DS101 Omni-Steth?
This device is designed for the detection, amplification, and recording of acoustic sounds from internal organs, including the heart, lungs, chest, abdomen, neck, limbs, arteries, and veins.
Which patient populations is this stethoscope suitable for?
The device is suitable for use with child, adolescent, and adult patients, allowing for versatile clinical application across different age groups.
Does the device support wireless connectivity?
Yes, the Cardiart DS101 Omni-Steth features a Bluetooth Class 2 wireless data link, which facilitates the transmission of captured acoustic data.
What is the regulatory status of this device?
The Cardiart DS101 Omni-Steth has received FDA 510K authorization under regulation number 870.1875, confirming it has been cleared for clinical use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Telemedicine stethoscope - DS101 - Cardiart by Imediplus - for teaching ..., Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic ..., PDF 003_Electronic Stethoscope DS101 User Manual_0222
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182196 | Class II | Active |
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Manufacturer
- Manufacturer
- Imediplus Inc.
- FDA Applicant
- Imediplus, Inc.
Sources (1)
- FDA 510(k) K182196 24 fields · synced Sep 23, 2026