Delica
Transcranial Doppler Ultrasound System with Robotic Probe Headband
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Delica Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 5 |
Record
| Listed by | Shenzhen Delica Medical Equipment Co., Ltd., China |
|---|---|
| FDA product code | OQQ |
| Device type | Diagnostic Ultrasonic Transducer, Robotic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1570 |
| Establishment | Manufacturer |
| 510(k) | K122710 |
| Record published | 2016-09-19 |
| Record revised | 2023-11-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EMS-9PB | In distribution | |
| EMS-9F | 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.