Identity
- Trade Name
- EART FDA UDI
- Generic Name
- Electrocardiographic long-term ambulatory recording analyser application software FDA UDI
- Device Name
- ECG Analysis and Reporting Tool. FDA UDI
- Model / Reference
- 10-501 FDA UDI
- Description
- ECG Analysis and Reporting Tool. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 17540279105018 FDA UDI
- 510(k) Number
- K223049 FDA UDI
- FDA Product Code
- DSH FDA UDIDQK FDA UDI
- GMDN Term
- Electrocardiographic long-term ambulatory recording analyser application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2800 FDA UDI870.1425 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: Electrocardiographic long-term ambulatory recording analyser application software
Eart by Icentia Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K223049 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
- Icentia Llc
Sources (1)
- FDA UDI 128ed7ae-514e-4767-85c8-100c853472ef 34 fields · synced May 31, 2026