The following data is part of a premarket notification filed by Shenzhen Changke Connect Electronics Co., Ltd. with the FDA for Ecg Cable.
| Device ID | K191428 |
| 510k Number | K191428 |
| Device Name: | 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 |
| Contact | Yahui Zhou |
| Correspondent | Yahui Zhou Shenzhen Changke Connect Electronics Co., Ltd. A2-4th Floor Of Xiang Dali Technology Park No.87 Of HengPing Road, Henggang Longgang District, Shenzhen, CN |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-29 |
| Decision Date | 2019-11-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973874210056 | K191428 | 000 |
| 06973874210049 | K191428 | 000 |
| 06973874210032 | K191428 | 000 |
| 06973874210025 | K191428 | 000 |
| 06973874210018 | K191428 | 000 |