The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Z6 Diagnostic Ultrasound System.
| Device ID | K182603 |
| 510k Number | K182603 |
| Device Name: | Z6 Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Shenzhen Mindray Bio-medical Electronics Co., LTD Keji 12th Road South, Hi-tech Industrial Park Shenzhen, CN 518057 |
| Contact | Jiang Xiaoyong |
| Correspondent | Jiang Xiaoyong Shenzhen Mindray Bio-medical Electronics Co., LTD Keji 12th Road South, Hi-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 | 2018-09-21 |
| Decision Date | 2018-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904098104 | K182603 | 000 |
| 06936415911324 | K182603 | 000 |
| 06936415911270 | K182603 | 000 |
| 06936415911263 | K182603 | 000 |
| 06944904088556 | K182603 | 000 |
| 06944904088549 | K182603 | 000 |
| 06944904088532 | K182603 | 000 |
| 06936415911317 | K182603 | 000 |