510(k) K233409
K233409 is an FDA 510(k) premarket notification submitted by Eko Health, Inc. for the device "Eko Low Ejection Fraction Tool (ELEFT)". The FDA issued a decision of Substantially Equivalent on March 28, 2024. The device falls under product code QYE (Reduced Ejection Fraction Machine Learning-Based Notification Software), a Class II device regulated under 21 CFR 870.2380. Eko Health, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 28, 2024
- Date Received
- October 6, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reduced Ejection Fraction Machine Learning-Based Notification Software
- Device Class
- Class II
- Regulation Number
- 870.2380
- Review Panel
- CV
- Submission Type
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.