The following data is part of a premarket notification filed by Shenzhen Wisonic Medical Technology Co.,ltd. with the FDA for Labat Series Diagnostic Ultrasound System.
| Device ID | K210154 |
| 510k Number | K210154 |
| Device Name: | Labat Series Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Shenzhen Wisonic Medical Technology Co.,Ltd. 1st, 2nd, 5th & 6th Floor, NO.6 Building, Pingshan Technology Park,Taoyuan Street, Nanshan District Shenzhen, CN 518055 |
| Contact | Jiang Xiaosan |
| Correspondent | Jiang Xiaosan Shenzhen Wisonic Medical Technology Co.,Ltd. 1st, 2nd, 5th & 6th Floor, NO.6 Building, Pingshan Technology Park,Taoyuan Street, Nanshan District Shenzhen, CN 518055 |
| 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 | 2021-01-21 |
| Decision Date | 2021-07-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971355420611 | K210154 | 000 |
| 06971355420635 | K210154 | 000 |
| 06971355420628 | K210154 | 000 |
| 06971355420604 | K210154 | 000 |
| 06971355420598 | K210154 | 000 |
| 06971355420772 | K210154 | 000 |
| 06971355420802 | K210154 | 000 |
| 06971355420796 | K210154 | 000 |
| 06971355420789 | K210154 | 000 |
| 06971355420840 | K210154 | 000 |
| 06971355420833 | K210154 | 000 |
| 06971355420826 | K210154 | 000 |
| 06971355420642 | K210154 | 000 |
| 06971355420659 | K210154 | 000 |
| 06971355420666 | K210154 | 000 |
| 06971355420581 | K210154 | 000 |
| 06971355420765 | K210154 | 000 |
| 06971355420758 | K210154 | 000 |
| 06971355420741 | K210154 | 000 |
| 06971355420734 | K210154 | 000 |
| 06971355420727 | K210154 | 000 |
| 06971355420710 | K210154 | 000 |
| 06971355420703 | K210154 | 000 |
| 06971355420697 | K210154 | 000 |
| 06971355420680 | K210154 | 000 |
| 06971355420673 | K210154 | 000 |
| 06971355420819 | K210154 | 000 |