Stethophone Pro
Smartphone-based digital stethoscope application for iPhone with OTC access to recording and core features, and prescription (Rx)-only access to AI-generated analysis results
3manufacturers in China registered for this device type
2catalogue numbers in this listing
4510(k) clearances naming this product code
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) | K252595 |
| Record published | 2026-02-18 |
| Record revised | 2026-02-19 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | manufacturing date |
| Distribution end date | 2026-02-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3.8.x and newer | In distribution | |
| 3.x.x | Withdrawn |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 |
| 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 |
| 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.