The following data is part of a premarket notification filed by Sonoscape Medical Corp. with the FDA for P10 Series Digital Color Doppler Ultrasound System.
| Device ID | K173058 |
| 510k Number | K173058 |
| Device Name: | P10 Series Digital Color Doppler Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Sonoscape Medical Corp. 4/f, 5/f, 8/f, 9/f & 10/f Yizhe Building, Yuquan Road, Nanshan Shenzhen, CN 518051 |
| Contact | Toki Wu |
| Correspondent | Toki Wu Sonoscape Medical Corp. 4/f, 5/f, 8/f, 9/f & 10/f Yizhe Building, Yuquan Road, Nanshan Shenzhen, CN 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 | 2017-09-28 |
| Decision Date | 2017-12-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945868611057 | K173058 | 000 |
| 06945868602833 | K173058 | 000 |
| 06945868602826 | K173058 | 000 |
| 06945868602819 | K173058 | 000 |
| 06945868602802 | K173058 | 000 |
| 06945868602796 | K173058 | 000 |
| 06945868602789 | K173058 | 000 |
| 06945868602772 | K173058 | 000 |
| 06945868602765 | K173058 | 000 |
| 06945868602758 | K173058 | 000 |
| 06945868602741 | K173058 | 000 |
| 06945868602734 | K173058 | 000 |
| 06945868602840 | K173058 | 000 |
| 06945868602857 | K173058 | 000 |
| 06945868611040 | K173058 | 000 |
| 06945868611033 | K173058 | 000 |
| 06945868611026 | K173058 | 000 |
| 06945868611019 | K173058 | 000 |
| 06945868611002 | K173058 | 000 |
| 06945868602710 | K173058 | 000 |
| 06945868602703 | K173058 | 000 |
| 06945868602697 | K173058 | 000 |
| 06945868602659 | K173058 | 000 |
| 06945868602642 | K173058 | 000 |
| 06945868602864 | K173058 | 000 |
| 06945868602727 | K173058 | 000 |