The following data is part of a premarket notification filed by Shenzzhen Luckcome Technology Inc., Ltd. with the FDA for Fetal Doppler, Model Fd88.
| Device ID | K182710 |
| 510k Number | K182710 |
| Device Name: | Fetal Doppler, Model FD88 |
| Classification | Monitor, Ultrasonic, Fetal |
| Applicant | ShenzZhen Luckcome Technology Inc., Ltd. Floor 6A, 6th Building , Tongfuyu Industrial Park, Nanshan District Shenzhen, CN 518055 |
| Contact | Can He |
| Correspondent | Linli He ShenzZhen Luckcome Technology Inc., Ltd. Floor 6A, 6th Building , Tongfuyu Industrial Park, Nanshan District Shenzhen, CN 518055 |
| Product Code | KNG |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-27 |
| Decision Date | 2019-03-01 |
| Summary: | summary |