The following data is part of a premarket notification filed by Guangdong Youkey Medical Co., Ltd. with the FDA for Pocket Ultrasound System.
| Device ID | K211746 |
| 510k Number | K211746 |
| Device Name: | Pocket Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | GuangDong Youkey Medical Co., Ltd. Unit 601, Block B, Building 1, B1 District, Hantian Technology City, Nanhai District Foshan, CN 528203 |
| Contact | Hu Zeyi |
| Correspondent | Hu Zeyi GuangDong Youkey Medical Co., Ltd. Unit601,6/F,Block B,Building 1,B1 District,Hantian TechnologyCity,Dongping Rd,Pingxi Shanghai Village Guichen Street,nanhai District, Foshan C, CN 528203 |
| 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 | 2021-06-07 |
| Decision Date | 2022-02-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06974757650136 | K211746 | 000 |
| 06974757650129 | K211746 | 000 |
| 06974757650112 | K211746 | 000 |
| 06974757650105 | K211746 | 000 |
| 06974757650099 | K211746 | 000 |
| 06974757650082 | K211746 | 000 |
| 06974757650075 | K211746 | 000 |