The following data is part of a premarket notification filed by Qingdao Hisense Medical Equipment Co., Ltd. with the FDA for Hi-light Diagnostic Ultrasound Systems.
| Device ID | K151709 |
| 510k Number | K151709 |
| Device Name: | Hi-Light Diagnostic Ultrasound Systems |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Qingdao Hisense Medical Equipment Co., Ltd. No. 169 Songling Road, Laoshan District Qingdao, CN 266071 |
| Contact | Wang Wei |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-06-24 |
| Decision Date | 2015-07-17 |
| Summary: | summary |