The following data is part of a premarket notification filed by Vcomin Technology Limited with the FDA for Fetal Doppler (models: Fd-231b, Fd-231d, Fd-640b, Fd-640d, Fd-200b, Fd-200d, Fd-591b, And Fd-591d).
| Device ID | K182526 |
| 510k Number | K182526 |
| Device Name: | Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, And FD-591D) |
| Classification | Monitor, Ultrasonic, Fetal |
| Applicant | Vcomin Technology Limited 2&3 FI., No. 1, Kangzheng Rd., Buji Town Shenzhen, CN 518110 |
| Contact | Han Jielin |
| Correspondent | Lucy Yan Shenzhen Joyantech Consulting Co., Ltd. 1122#, International Mayor Communication Center 55 Shizhou Zhong Road, Nanshan District Shenzhen, CN 518000 |
| Product Code | KNG |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-11 |
| Decision Date | 2019-05-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970442090256 | K182526 | 000 |
| 16970442090307 | K182526 | 000 |
| 16970442090291 | K182526 | 000 |
| 16970442090284 | K182526 | 000 |
| 16970442090277 | K182526 | 000 |
| 16970442090260 | K182526 | 000 |
| 16970442090031 | K182526 | 000 |
| 16970442090406 | K182526 | 000 |
| 16970442090390 | K182526 | 000 |
| 16970442090383 | K182526 | 000 |
| 16970442090376 | K182526 | 000 |
| 16970442090369 | K182526 | 000 |
| 16970442090352 | K182526 | 000 |
| 16970442090345 | K182526 | 000 |
| 16970442090338 | K182526 | 000 |
| 06970442090430 | K182526 | 000 |
| 16970442090420 | K182526 | 000 |
| 16970442090314 | K182526 | 000 |
| 16970442090321 | K182526 | 000 |
| 06970442090249 | K182526 | 000 |
| 06970442090232 | K182526 | 000 |
| 06970442090225 | K182526 | 000 |
| 06970442090218 | K182526 | 000 |
| 06970442090201 | K182526 | 000 |
| 06970442090171 | K182526 | 000 |
| 06970442090164 | K182526 | 000 |
| 06970442090096 | K182526 | 000 |
| 06970442090089 | K182526 | 000 |
| 06970442090072 | K182526 | 000 |
| 06970442090065 | K182526 | 000 |
| 06970442090058 | K182526 | 000 |
| 06970442090041 | K182526 | 000 |
| 06970442090027 | K182526 | 000 |
| 00697044209003 | K182526 | 000 |
| 16970442090000 | K182526 | 000 |
| 06970442090416 | K182526 | 000 |