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 |