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 | K173801 |
| 510k Number | K173801 |
| Device Name: | Transcranial Doppler Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Shenzhen Delica Medical Equipment Co., Ltd. 6C, Block 10, The Second Industrial Zone Guanlong, Nanshan District Shenzhen, CN 518055 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-14 |
| Decision Date | 2018-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970481940086 | K173801 | 000 |
| 06970481940079 | K173801 | 000 |