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