The following data is part of a premarket notification filed by Chison Medical Technologies Co., Ltd. with the FDA for Sonoeye P5/ Sonoeye V5/ Sonoeye G5 Digital Color Doppler Palm Ultrasound System.
| Device ID | K201971 |
| 510k Number | K201971 |
| Device Name: | SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Chison Medical Technologies Co., Ltd. No.228, Changjiang East Road, Block 51 And 53, Phase 5, Shuofang Industrial Park Wuxi, CN 214142 |
| Contact | Qifei Liu |
| Correspondent | Qifei Liu Chison Medical Technologies Co., Ltd. No.228, Changjiang East Road, Block 51 And 53, Phase 5, Shuofang Industrial Park, Xinwu District Wuxi, CN 214142 |
| 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 | 2020-07-15 |
| Decision Date | 2021-02-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945121413091 | K201971 | 000 |
| 06945121413688 | K201971 | 000 |