The following data is part of a premarket notification filed by Shenzhen Taikang Medical Equipment Co., Ltd. with the FDA for Fetal Doppler.
Device ID | K211940 |
510k Number | K211940 |
Device Name: | Fetal Doppler |
Classification | Monitor, Ultrasonic, Fetal |
Applicant | Shenzhen Taikang Medical Equipment Co., Ltd. 3F East, Building 4, Lanzhu East Road 8, Grand Industrial Park, Pingshan District Shenzhen, CN 518015 |
Contact | Shigui Du |
Correspondent | Shigui Du Shenzhen Taikang Medical Equipment Co., Ltd. 3F East, Building 4, Lanzhu East Road 8, Grand Industrial Park, Pingshan District Shenzhen, CN 518015 |
Product Code | KNG |
CFR Regulation Number | 884.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-06-23 |
Decision Date | 2022-01-07 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FETAL DOPPLER 90794910 not registered Live/Pending |
Wu, Jingmei 2021-06-25 |