FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Eko Low Ejection Fraction Tool (ELEFT)
K Number: K233409
·
Decision Mar 28, 2024
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
4
Applicant Total
3
Review Days
174
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Basic Information
- Device Name
- Eko Low Ejection Fraction Tool (ELEFT)
- K Number
- K233409
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2380
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Eko Health, Inc.
- Date Received
- October 6, 2023
- Decision Date
- March 28, 2024
- Product Code
- QYE
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QYE | Reduced Ejection Fraction Machine Learning-Based Notification Software | FDA class 2 | Cardiovascular |
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