The following data is part of a premarket notification filed by Xinkang Medical Instrument Co., Ltd with the FDA for Ecg Cables And Leadwires.
| Device ID | K201359 |
| 510k Number | K201359 |
| Device Name: | ECG Cables And Leadwires |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | Xinkang Medical Instrument Co., Ltd 2 Floor, Puhua Science And Technology Park, Tongsheng Community Dalang Shenzhen, CN 518109 |
| Contact | Xu Changsheng |
| Correspondent | Field Fu Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square Nanshan District Shenzhen, CN 518100 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-21 |
| Decision Date | 2020-10-01 |