Stethophone
Stethophone is an electronic stethoscope software application that operates on smartphones. It captures, amplifies, filters and transmits heart and lung auscultation sounds so a clinician…
Stethophone is an electronic stethoscope software application that operates on smartphones. It captures, amplifies, filters and transmits heart and lung auscultation sounds so a clinician can listen to sounds acquired on site or at another location.
The FDA filing specifies adult patients and use by professional or lay users in clinical or nonclinical environments. It states that the device is not intended for self-diagnosis.
Listed Item
Smartphone stethoscope software application for iPhones
Use and Sound Capture
The filing describes Stethophone as designed for healthcare professionals and home users. It enables capture and amplification of chest sounds, and the comparison section identifies smartphone microphone input, iOS software and heart and lung sounds.
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 | Sparrow Acoustics Inc., Canada |
|---|---|
| FDA product code | DQD |
| Device type | Stethoscope, Electronic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1875 |
| Establishment | Manufacturer |
| 510(k) | K231551 |
| Record published | 2024-01-18 |
| Record revised | 2026-02-13 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Distribution end date | 2026-02-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2.x.x | Withdrawn |
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 |
| Core 500 Digital Stethoscope – Bundle-ROG | Eko Devices, Inc. | 1 |
Showing 12 of 79. All products under Stethoscope, Electronic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252595 | 2025-09-12 |
| K240901 | 2024-09-19 |
| K231551 | 2023-10-12 |
| K222871 | 2023-03-29 |
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.