K163316 is an FDA 510(k) clearance for the Multi-Link X2 ECG Adapter and Direct Connect Lead Wire System. This device is classified as a Cable, Transducer And Electrode, Patient, (including Connector) (Class II - Special Controls, product code DSA).
Submitted by Carefusion 303, Inc. (Vernon Hills, US). The FDA issued a Cleared decision on June 22, 2017, 211 days after receiving the submission on November 23, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2900.
| 510(k) Number | K163316 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 2016 |
| Decision Date | June 22, 2017 |
| Days to Decision | 211 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 |