The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Hepatus 7/hepatus 6/hepatus 5/hepatus 7s/hepatus 6s/hepatus 5s/hepatus 7t/hepatus 6t/hepatus 5t/fibrous 7/fibrous.
| Device ID | K200643 |
| 510k Number | K200643 |
| Device Name: | Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous |
| 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 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 | 2020-03-11 |
| Decision Date | 2020-07-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904001463 | K200643 | 000 |
| 06936415975074 | K200643 | 000 |
| 06936415975081 | K200643 | 000 |
| 06936415975098 | K200643 | 000 |
| 06936415975104 | K200643 | 000 |
| 06936415975111 | K200643 | 000 |
| 06936415975128 | K200643 | 000 |
| 06936415975135 | K200643 | 000 |
| 06936415975142 | K200643 | 000 |
| 06936415975159 | K200643 | 000 |
| 06936415975166 | K200643 | 000 |
| 06936415975173 | K200643 | 000 |
| 06936415927806 | K200643 | 000 |
| 06936415983444 | K200643 | 000 |
| 06936415983567 | K200643 | 000 |
| 06936415983604 | K200643 | 000 |
| 06936415970895 | K200643 | 000 |