ECG Disposable Lead Wire

Cable, Transducer And Electrode, Patient, (including Connector)

APK Technology Co., Ltd.

The following data is part of a premarket notification filed by Apk Technology Co., Ltd. with the FDA for Ecg Disposable Lead Wire.

Pre-market Notification Details

• Device ID: K170536
• 510k Number: K170536
• Device Name: ECG Disposable Lead Wire
• Classification: Cable, Transducer And Electrode, Patient, (including Connector)
• Applicant: APK Technology Co., Ltd. 6Floor, B2 Building, Industry Of Hengfeng Hezhou, Xixiang, Bao'an Distric Shenzhen, CN 518126
• Contact: Caifang Wang
• Correspondent: Diana Hong; Mid-Link Consulting Co.,Ltd P.O. BOX 120-119 Shanghai, CN 200120
• Product Code: DSA
• CFR Regulation Number: 870.2900 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-02-23
• Decision Date: 2017-04-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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