Fetal Doppler
Monitor, Ultrasonic, Fetal
Shenzhen AOJ Medical Technology Co., Ltd.
The following data is part of a premarket notification filed by Shenzhen Aoj Medical Technology Co., Ltd. with the FDA for Fetal Doppler.
Pre-market Notification Details
| Device ID | K182190 |
| 510k Number | K182190 |
| Device Name: | Fetal Doppler |
| Classification | Monitor, Ultrasonic, Fetal |
| Applicant | Shenzhen AOJ Medical Technology Co., Ltd. Room 202, HaoGu Industry Park, 2037 Guanguang Road, Guangming District Shenzhen, CN 518105 |
| Contact | Qihuan Zhao |
| Correspondent | Qihuan Zhao Shenzhen AOJ Medical Technology Co., Ltd. Room 202, HaoGu Industry Park, 2037 Guanguang Road, Guangming District Shenzhen, CN 518105 |
| Product Code | KNG |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-13 |
| Decision Date | 2018-12-19 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972040110534 | K182190 | 000 |
Trademark Results [Fetal Doppler]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FETAL DOPPLER 90794910 not registered Live/Pending |
Wu, Jingmei 2021-06-25 |
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