CONTEC™ Electrocardiograph

Electrocardiograph

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 Contec™ Electrocardiograph.

Pre-market Notification Details

• Device ID: K171360
• 510k Number: K171360
• Device Name: CONTEC™ Electrocardiograph
• Classification: Electrocardiograph
• Applicant: Contec Medical Systems Co., LTD. No. 112 QinHuang West Street Economic & Technical Development Zone Qinhuangdao, CN 066012
• Contact: Xueyong Li
• Correspondent: Ray Wang; Beijing Believe Technology Service Co., Ltd. 5-402, Building #27, YangGuangYiShang, No.56, LiangXiang East Rd., Fangshan Dist,beijing,, CN 102401
• Product Code: DPS
• CFR Regulation Number: 870.2340 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-05-09
• Decision Date: 2018-01-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
06945040103462	K171360	000