K191428 is an FDA 510(k) clearance for the ECG Cable. This device is classified as a Cable, Transducer And Electrode, Patient, (including Connector) (Class II - Special Controls, product code DSA).
Submitted by Shenzhen Changke Connect Electronics Co., Ltd. (Longgang District, Shenzhen, CN). The FDA issued a Cleared decision on November 27, 2019, 182 days after receiving the submission on May 29, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2900.
| 510(k) Number | K191428 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 29, 2019 |
| Decision Date | November 27, 2019 |
| Days to Decision | 182 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DSA - Cable, Transducer And Electrode, Patient, (including Connector) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2900 |