Omni-Steth Electronic Stethoscope
The Omni-Steth Electronic Stethoscope detects, amplifies and records internal body sounds during physical examination. It is intended for children, adolescents and adults in clinics or…
The Omni-Steth Electronic Stethoscope detects, amplifies and records internal body sounds during physical examination. It is intended for children, adolescents and adults in clinics or hospitals, including listening to the heart, lungs, chest, abdomen and blood vessels.
A digital signal processor filters and amplifies the detected sounds for listening through the headset. The battery-powered unit has a colour OLED display and recording controls, and can display an acoustically derived heart rate when consistent heart sounds are present.
Listed Item
The Electronic Stethoscope Omni-Steth 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. And the stethoscope chest piece is designed for use with child, adolescent and adult patients. It is used for any subject undergoing a physical examination and intended only for medical diagnostic purposes in clinic or hospital.
Audio Transfer
A Bluetooth connection can transfer raw audio to an external device such as a computer. The stethoscope can perform its intended examination functions independently without that connection.
Who Else Makes It
Concentrated in Zhejiang (1), Guangdong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Yahorng Dongguan Electronic Co Ltd | Guangdong | Guangdong | Contract manufacturer | 8 |
| ADC Ningbo Co., Ltd. | Ningbo | Zhejiang | Exporter | 13 |
| Suzhou Melodicare Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | Imediplus, Inc., Taiwan |
|---|---|
| FDA product code | DQD |
| Device type | Stethoscope, Electronic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1875 |
| 510(k) | K182196 |
| Record published | 2019-01-08 |
| Record revised | 2024-11-25 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Omni-Steth | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 3M™ Littmann® | 3M Company | 29 |
| Adscope® | American Diagnostic Corp. | 14 |
| Littmann® | 3M Company | 13 |
| RNK Products | Rnk Products, Inc. | 10 |
| Tyto Stethoscope | Tyto Care, Ltd. | 5 |
| Steth IO | Steth IO | 4 |
| Heroic Faith | Heroic Faith International Ltd. | 3 |
| Stethophone Pro | Sparrow Acoustics Inc. | 2 |
| AeviceMD | Aevice Health Pte. Ltd. | 2 |
| Eko Core 500 and CAC500 Founder’s Edition bundle | Eko Devices, Inc. | 1 |
| Eko Core 500 and CAC500 Standard bundle | Eko Devices, Inc. | 1 |
| Stethophone | Sparrow Acoustics Inc. | 1 |
Showing 12 of 79. All products under Stethoscope, Electronic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K182196 | 2018-09-11 |
| K173663 | 2018-08-17 |
| K160023 | 2016-09-30 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.