The following data is part of a premarket notification filed by Shenzhen Well.d Medical Electronics Co., Ltd. with the FDA for Color Doppler Ultrasound System; Model: Meye1 And Meye2.
| Device ID | K182165 |
| 510k Number | K182165 |
| Device Name: | Color Doppler Ultrasound System; Model: MEye1 And MEye2 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Shenzhen Well.D Medical Electronics Co., LTD. Well.d Park, Qinglan 3 Rd, National Biopharmaceutical Industrial Base, Pingshan Shenzhen, CN 518118 |
| Contact | Ning Bai |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| 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 | 2018-08-10 |
| Decision Date | 2018-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972174670027 | K182165 | 000 |
| 06972174670010 | K182165 | 000 |