The following data is part of a premarket notification filed by Chison Medical Technologies Co., Ltd. with the FDA for Sonoeye P1/ Sonoeye P1-g/ Sonoeye V1/ Sonoeye V1-g/ Sonoeye G1/ Sonoeye G1-g Digital Color Doppler Palm Ultrasound System.
Device ID | K201965 |
510k Number | K201965 |
Device Name: | SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G 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 | 2021-03-02 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06945121413060 | K201965 | 000 |