The following data is part of a premarket notification filed by Contec Medical Systems Co., Ltd. with the FDA for Cms600p2 B-ultrasound Diagnostic System.
Device ID | K170856 |
510k Number | K170856 |
Device Name: | CMS600P2 B-Ultrasound Diagnostic System |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | Contec Medical Systems Co., LTD. No. 112 Qinhuang West Street Economic & Technical Development Zone Qinhuangdao, CN 066004 |
Contact | Xueyong Li |
Correspondent | Ray Wang Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, DaFangJu, No.25 BanBiDian Road Liyuan Town, Tongzhou District, CN 101121 |
Product Code | IYO |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-03-22 |
Decision Date | 2017-11-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06945040101161 | K170856 | 000 |