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 |