The following data is part of a premarket notification filed by Shenzhen Imdk Medical Technology Co., Ltd. with the FDA for Ultrasonic Doppler (model Ym-2t8).
| Device ID | K180419 |
| 510k Number | K180419 |
| Device Name: | Ultrasonic Doppler (Model YM-2T8) |
| Classification | Monitor, Ultrasonic, Fetal |
| Applicant | Shenzhen IMDK Medical Technology Co., Ltd. C Zone, 10F, Building16, Yuanshan Industrial B Area Gongming Street, Guangming Shenzhen, CN 518106 |
| Contact | Yuan Xia |
| Correspondent | Yuan Xia Shenzhen IMDK Medical Technology Co., Ltd. C Zone, 10F, Building16, Yuanshan Industrial B Area Gongming Street, Guangming Shenzhen, CN 518106 |
| Product Code | KNG |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-15 |
| Decision Date | 2018-07-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973912940051 | K180419 | 000 |
| 06973912940020 | K180419 | 000 |