The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Zs3 Ultrasound System, Z.one Pro Ultrasound System.
| Device ID | K171891 |
| 510k Number | K171891 |
| Device Name: | ZS3 Ultrasound System, Z.one Pro Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen, CN 518057 |
| Contact | Zhai Pei |
| Correspondent | Zhai Pei Shenzhen Mindray Bio-Medical Electronics Co., Ltd Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan 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 | 2017-06-26 |
| Decision Date | 2017-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904098746 | K171891 | 000 |
| 06936415903787 | K171891 | 000 |
| 06936415903794 | K171891 | 000 |
| 06936415910372 | K171891 | 000 |
| 06936415902537 | K171891 | 000 |
| 06936415902780 | K171891 | 000 |
| 06936415902797 | K171891 | 000 |
| 06936415902803 | K171891 | 000 |
| 06936415902810 | K171891 | 000 |
| 06936415906245 | K171891 | 000 |
| 06944904098722 | K171891 | 000 |
| 06944904098739 | K171891 | 000 |
| 06936415903497 | K171891 | 000 |