The following data is part of a premarket notification filed by Shenzhen Delica Medical Equipment Co., Ltd. with the FDA for Transcranial Doppler Ultrasound System.
| Device ID | K190228 |
| 510k Number | K190228 |
| Device Name: | Transcranial Doppler Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Shenzhen Delica Medical Equipment Co., Ltd. F, Block 10, The Second Industrial Zone Guanlong, Nanshan District Shenzhen, CN 51855 |
| Contact | Yolanda Lan |
| Correspondent | Yolanda Lan Shenzhen Delica Medical Equipment Co., Ltd. F, Block 10, The Second Industrial Zone Guanlong, Nanshan District Shenzhen, CN 51855 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | OQQ |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-05 |
| Decision Date | 2019-06-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970481940109 | K190228 | 000 |
| 06970481940093 | K190228 | 000 |