CMS600P2 B-Ultrasound Diagnostic System

System, Imaging, Pulsed Echo, Ultrasonic

Contec Medical Systems Co., LTD.

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.

Pre-market Notification Details

Device IDK170856
510k NumberK170856
Device Name:CMS600P2 B-Ultrasound Diagnostic System
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant Contec Medical Systems Co., LTD. No. 112 Qinhuang West Street Economic & Technical Development Zone Qinhuangdao,  CN 066004
ContactXueyong Li
CorrespondentRay Wang
Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, DaFangJu, No.25 BanBiDian Road Liyuan Town, Tongzhou District,  CN 101121
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-03-22
Decision Date2017-11-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06945040101161 K170856 000

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