The following data is part of a premarket notification filed by Weipeng (suzhou) Medical Devices Co., Ltd. with the FDA for Acusee As-p1000 System.
| Device ID | K202119 |
| 510k Number | K202119 |
| Device Name: | AcuSee AS-P1000 System |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Weipeng (Suzhou) Medical Devices Co., Ltd. Unit 207, Building B2, Biobay, 218 Xinghu St., Suzhou Industrial Park Suzhou, CN 215123 |
| Contact | Bin Yang |
| Correspondent | Geetha Rao Springborne Life Sciences 750 Menlo Avenue, Suite 200 Menlo Park, CA 94025 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-30 |
| Decision Date | 2020-10-07 |