The following data is part of a premarket notification filed by Shenzhen Changke Connect Electronics Co., Ltd. with the FDA for Disposable Ecg Cable.
| Device ID | K200026 |
| 510k Number | K200026 |
| Device Name: | Disposable ECG Cable |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | Shenzhen Changke Connect Electronics Co., Ltd. A2-4th Floor Of Xiang Dali Technology Park, No.87 Of HengPing Road, Henggang, Longgang District, Shenzhen, CN 518000 |
| Contact | Yahui Zhou |
| Correspondent | Kevin Wang Chonconn Medical Device Consulting Co., Ltd. No. A415, Block A, NanShan Medical Devices Industrial Park Nanshan District, Shenzhen, CN 518067 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-06 |
| Decision Date | 2020-05-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16973874210138 | K200026 | 000 |
| 06973874210131 | K200026 | 000 |