The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Zs3 And Z.one Pro Ultrasound Systems.
| Device ID | K192410 |
| 510k Number | K192410 |
| Device Name: | ZS3 And Z.one Pro Ultrasound Systems |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ShenZhen Mindray Bio-Medical Electronics Co., Ltd Keji 12th Road South, High-tech Industrial Park, Shenzhen, CN 518057 |
| Contact | Jiang Haosen |
| Correspondent | Jiang Haosen ShenZhen Mindray Bio-Medical Electronics Co., Ltd Keji 12th Road South, High-tech Industrial Park, Shenzhen, CN 518057 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-04 |
| Decision Date | 2019-12-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06936415919382 | K192410 | 000 |
| 06936415919375 | K192410 | 000 |
| 06936415919368 | K192410 | 000 |
| 06936415970888 | K192410 | 000 |