K192004 is an FDA 510(k) clearance for the Eko Analysis Software. This device is classified as a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MWI).
Submitted by Eko Devices, Inc. (Berkeley, US). The FDA issued a Cleared decision on January 15, 2020, 173 days after receiving the submission on July 26, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K192004 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 26, 2019 |
| Decision Date | January 15, 2020 |
| Days to Decision | 173 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MWI - Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2300 |