The following data is part of a premarket notification filed by Qingdao Hisense Medical Equipment Co., Ltd with the FDA for Hd60 Series Ultrasound Diagnostic System.
| Device ID | K213862 |
| 510k Number | K213862 |
| Device Name: | HD60 Series Ultrasound Diagnostic System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Qingdao Hisense Medical Equipment Co., Ltd No. 399 Songling Road, Laoshan District Qingdao, CN 266100 |
| Contact | Yalan Wu |
| Correspondent | Yalan Wu Qingdao Hisense Medical Equipment Co., Ltd No. 399 Songling Road, Laoshan District Qingdao, CN 266100 |
| 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 | 2021-12-10 |
| Decision Date | 2022-06-08 |