The following data is part of a premarket notification filed by Contec Medical Systems Co., Ltd. with the FDA for Pocket Fetal Doppler (models Contec10c And Contec10cl).
| Device ID | K220245 |
| 510k Number | K220245 |
| Device Name: | Pocket Fetal Doppler (Models CONTEC10C And CONTEC10CL) |
| Classification | Monitor, Ultrasonic, Fetal |
| Applicant | Contec Medical Systems Co., Ltd. No.112 Qinhuang West Street, Economic & Technical Development Zone Qinhuangdao, CN |
| Contact | Jie Xiao |
| Correspondent | Ray Wang Beijing Believe-Med Technology Service Co., Ltd. Rm. 912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, CN 102401 |
| Product Code | KNG |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-28 |
| Decision Date | 2022-09-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945040105411 | K220245 | 000 |
| 06945040105404 | K220245 | 000 |