The following data is part of a premarket notification filed by Shenzhen Coreray Technology., Ltd with the FDA for Ecg Cable/leadwires.
| Device ID | K172797 |
| 510k Number | K172797 |
| Device Name: | ECG Cable/Leadwires |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | Shenzhen Coreray Technology., Ltd ChuangYe Technology Park,1th Dong Huan Road, Longhua New District Shenzhen, CN 518109 |
| Contact | Simon Fan |
| Correspondent | Field Fu Shenzhen Joyantech Consulting Co., Ltd. Shizhou Zhong Road 55#,Na 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 | 2017-09-15 |
| Decision Date | 2018-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06928737883564 | K172797 | 000 |
| 06928737883557 | K172797 | 000 |
| 06928737883540 | K172797 | 000 |
| 06928737883533 | K172797 | 000 |