The following data is part of a premarket notification filed by Sonoscape Company Limited with the FDA for S9 Portable Digital Color Doppler Ultrasound System.
| Device ID | K142710 |
| 510k Number | K142710 |
| Device Name: | S9 Portable Digital Color Doppler Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SONOSCAPE COMPANY LIMITED YIZHE BUILDING, YUQUAN ROAD, NANSHAN Shenzhen, TW 518051 |
| Contact | Toki Wu |
| Correspondent | Toki Wu SONOSCAPE COMPANY LIMITED YIZHE BUILDING, YUQUAN ROAD, NANSHAN Shenzhen, TW 518051 |
| 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 | 2014-09-22 |
| Decision Date | 2015-01-05 |
| Summary: | summary |