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 | K213009 |
| 510k Number | K213009 |
| Device Name: | Transcranial Doppler Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Shenzhen Delica Medical Equipment Co., Ltd. 18F, Building B, High-tech Park, Guangqiao Road, Tianliao Community, Yutang Street, Guangming Shenzhen, CN 518107 |
| Contact | Zhenhua Xiao |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| 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 | 2021-09-20 |
| Decision Date | 2022-07-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970481940178 | K213009 | 000 |
| 06970481940161 | K213009 | 000 |