The following data is part of a premarket notification filed by Sonoscape Medical Corp. with the FDA for P20 Series Digital Color Doppler Ultrasound System.
| Device ID | K172993 |
| 510k Number | K172993 |
| Device Name: | P20 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 | 2017-09-27 |
| Decision Date | 2017-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945868612078 | K172993 | 000 |
| B369MUS05164 | K172993 | 000 |
| B369MUS05163 | K172993 | 000 |
| B369MUS05162 | K172993 | 000 |
| B369MUS05161 | K172993 | 000 |
| B369MUS05160 | K172993 | 000 |
| B369MUS05159 | K172993 | 000 |
| B369MUS05158 | K172993 | 000 |
| B369MUS05157 | K172993 | 000 |
| B369MUS05156 | K172993 | 000 |
| B369MUS05155 | K172993 | 000 |
| B369MUS05140 | K172993 | 000 |
| B369MUS05138 | K172993 | 000 |
| B369MUS05137 | K172993 | 000 |
| B369MUS05136 | K172993 | 000 |
| B369MUS05135 | K172993 | 000 |
| B369MUS0176 | K172993 | 000 |
| B369MUS01029 | K172993 | 000 |
| B369MUS05165 | K172993 | 000 |
| B369MUS05166 | K172993 | 000 |
| 06945868612061 | K172993 | 000 |
| 06945868612054 | K172993 | 000 |
| 06945868612047 | K172993 | 000 |
| 06945868612030 | K172993 | 000 |
| 06945868612023 | K172993 | 000 |
| 06945868602680 | K172993 | 000 |
| 06945868602673 | K172993 | 000 |
| 06945868602666 | K172993 | 000 |
| B369MUS05176 | K172993 | 000 |
| B369MUS05175 | K172993 | 000 |
| B369MUS05173 | K172993 | 000 |
| B369MUS05172 | K172993 | 000 |
| B369MUS05171 | K172993 | 000 |
| B369MUS05170 | K172993 | 000 |
| B369MUS05169 | K172993 | 000 |
| B369MUS05168 | K172993 | 000 |
| B369MUS05167 | K172993 | 000 |
| B369MUS01025 | K172993 | 000 |