ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)— 510(k) K250652
Substantially EquivalentAnumana, Inc.
FDA 510(k) clearance K250652 for ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010), Substantially Equivalent on 2025-07-28. Applicant: Anumana, Inc.. Device class: 2.
Clearance details
- Applicant
- Anumana, Inc.
- Product code
- Code QYE
- Device class
- Class 2
- Regulation
- 21 CFR 870.2380
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cambridge, MA, US
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