K233409 is an FDA 510(k) clearance for the Eko Low Ejection Fraction Tool (ELEFT). This device is classified as a Reduced Ejection Fraction Machine Learning-based Notification Software (Class II - Special Controls, product code QYE).
Submitted by Eko Health, Inc. (Emeryville, US). The FDA issued a Cleared decision on March 28, 2024, 174 days after receiving the submission on October 6, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2380. Reduced Ejection Fraction Machine Learning-based Notification Software Employs Machine Learning Techniques To Suggest The Likelihood Of A Reduced Ejection Fraction For Further Referral Or Diagnostic Follow-up..
| 510(k) Number | K233409 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 06, 2023 |
| Decision Date | March 28, 2024 |
| Days to Decision | 174 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QYE - Reduced Ejection Fraction Machine Learning-based Notification Software |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2380 |
| Definition | Reduced Ejection Fraction Machine Learning-based Notification Software Employs Machine Learning Techniques To Suggest The Likelihood Of A Reduced Ejection Fraction For Further Referral Or Diagnostic Follow-up. |