The following data is part of a premarket notification filed by Beijing Choice Electronic Technololgy Co., Ltd. with the FDA for Fetal Doppler.
| Device ID | K112911 |
| 510k Number | K112911 |
| Device Name: | FETAL DOPPLER |
| Classification | Monitor, Ultrasonic, Fetal |
| Applicant | BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. P.O. BOX 237-023 Shanghai, CN 200237 |
| Contact | Diana Hong |
| Correspondent | Diana Hong BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. P.O. BOX 237-023 Shanghai, CN 200237 |
| Product Code | KNG |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-03 |
| Decision Date | 2011-10-27 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FETAL DOPPLER 90794910 not registered Live/Pending |
Wu, Jingmei 2021-06-25 |