PATIENT MONITOR

Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

CONTEC MEDICAL SYSTEM CO., LTD.

The following data is part of a premarket notification filed by Contec Medical System Co., Ltd. with the FDA for Patient Monitor.

Pre-market Notification Details

• Device ID: K101692
• 510k Number: K101692
• Device Name: PATIENT MONITOR
• Classification: Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
• Applicant: CONTEC MEDICAL SYSTEM CO., LTD. SUITE 8D , ZHONGXIN ZHONGSHAN MANSION, NO. 19, LANE 999, Zhong Shan, Shanghai, CN 200030
• Contact: Diana Hong
• Correspondent: Diana Hong; CONTEC MEDICAL SYSTEM CO., LTD. SUITE 8D , ZHONGXIN ZHONGSHAN MANSION, NO. 19, LANE 999, Zhong Shan, Shanghai, CN 200030
• Product Code: MHX
• Subsequent Product Code: BZQ
• Subsequent Product Code: CCK
• Subsequent Product Code: DQA
• Subsequent Product Code: DRT
• Subsequent Product Code: DSI
• Subsequent Product Code: DSK
• Subsequent Product Code: DXN
• Subsequent Product Code: FLL
• Subsequent Product Code: MLD
• CFR Regulation Number: 870.1025 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-06-16
• Decision Date: 2011-06-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
06945040100515	K101692	000
06945040100058	K101692	000
06945040100034	K101692	000