The following data is part of a premarket notification filed by Sonoscape Medical Corp. with the FDA for P12 Elite Series Digital Color Doppler Ultrasound System.
| Device ID | K221089 |
| 510k Number | K221089 |
| Device Name: | P12 Elite Series Digital Color Doppler Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Sonoscape Medical Corp. Room 201&202, 12th Building, Shenzhen Software Park Phase II 1 Keji Middle 2nd Road, Yuehai Subdistrict, Nanshan Shenzhen, CN 518057 |
| Contact | Toki Wu |
| Correspondent | Toki Wu Sonoscape Medical Corp. Room 201&202, 12th Building, Shenzhen Software Park Phase II 1 Keji Middle 2nd Road, Yuehai Subdistrict, Nanshan Shenzhen, CN 518057 |
| 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 | 2022-04-13 |
| Decision Date | 2022-09-15 |