Adscope®
Electronic Scope-658,Adult, Metallic Caribbean
3manufacturers in China registered for this device type
14catalogue numbers in this listing
3510(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 | American Diagnostic Corp., United States |
|---|---|
| FDA product code | DQD |
| Device type | Stethoscope, Electronic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1875 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K162589 |
| Record published | 2017-05-27 |
| Record revised | 2024-11-25 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number |
| Storage | Storage environment temperature -4 to 158 °F; Storage environment humidity 15 to 95 % RH |
| Packaging | Master case of 3 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 658OH | In distribution | |
| 658MCA | In distribution | |
| 658BD | In distribution | |
| 658MRS | In distribution | |
| 658-03 | In distribution | |
| 658PBCA | In distribution | |
| 658BAT | In distribution | |
| 658MCB | In distribution | |
| 658BK | In distribution | |
| 658MG | In distribution | |
| 658N | In distribution | |
| 658USB | In distribution | |
| 657BK | In distribution | |
| 658DG | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 3M™ Littmann® | 3M Company | 29 |
| 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 |
| 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 |
|---|---|
| K162589 | 2017-03-10 |
| K060321 | 2006-05-15 |
| K012304 | 2001-11-01 |
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.