ChestPal
Electronic stethoscope
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Vistar Medical Supplies Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Globalcare Medical Technology Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 9 |
Record
| Listed by | Chestpal Ltd, United Kingdom |
|---|---|
| FDA product code | OCR |
| Device type | Lung Sound Monitor |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1875 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-06-26 |
| Record revised | 2024-11-25 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Packaging | Box |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LUS110 | In distribution |
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.