K190593 is an FDA 510(k) clearance for the Zio XT ECG Monitoring System, Zio AT ECG Monitoring System. This device is classified as a Computer, Diagnostic, Programmable (Class II - Special Controls, product code DQK).
Submitted by iRhythm Technologies, Inc. (San Francisco, US). The FDA issued a Cleared decision on August 23, 2019, 169 days after receiving the submission on March 7, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1425.
| 510(k) Number | K190593 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 2019 |
| Decision Date | August 23, 2019 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQK - Computer, Diagnostic, Programmable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1425 |