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ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm
FDA UDIClass II (US FDA UDI)
by Anumana Inc.
Identity
- Trade Name
- ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm FDA UDI
- Generic Name
- Cardiopulmonary physiological parameter analysis software FDA UDI
- Model / Reference
- v 2.3.0 (1010) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860007426445 FDA UDI
- 510(k) Number
- K232699 FDA UDI
- FDA Product Code
- QYE FDA UDI
- GMDN Term
- Cardiopulmonary physiological parameter analysis software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2380 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cardiopulmonary physiological parameter analysis software
ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm by Anumana Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiopulmonary physiological parameter analysis software.
- LABSYSTEM™ PRO — Boston Scientific · Class I
- Viz HCM — Viz.ai · Class II
- ECG Plug-In — PREVENTICE TECHNOLOGIES, INC. · Class II
- Premier Heart MCG Analysis Software — PREMIER HEART, LLC · Class II
- PatientCare Platform — PREVENTICE TECHNOLOGIES, INC. · Class II
- Office Medic — Vectracor, Inc. · Class II
- RhythmAnalytics — Biofourmis Singapore Pte., Ltd. · Class II
- Premier Heart MCG Analysis API — PREMIER HEART, LLC · Class II
Cleared under the same submission
K232699 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Anumana Inc.
Sources (1)
- FDA UDI f1264d83-1979-4fb5-91a3-5a2653d89e27 33 fields · synced May 30, 2026