Identity
- Trade Name
- CardioConfirm FDA UDI
- Generic Name
- Cardiology information system application software FDA UDI
- Device Name
- Cardiology Data Software FDA UDI
- Model / Reference
- 11111-002-51 FDA UDI
- Description
- Cardiology Data Software FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817655020259 FDA UDI
- 510(k) Number
- FDA Product Code
- DQK FDA 510(k)DQX FDA UDI
- GMDN Term
- Cardiology information system application software FDA UDI
Classification
- Device Class
- Class II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 870.1425 FDA 510(k)
- Regulation Number
- 870.1425 FDA 510(k)870.1330 FDA UDI
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- 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
No
FDA UDI
CardioConfirm by Mortara Instrument, Inc. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161465 | Class II | Active |
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Manufacturer
- Manufacturer
- Mortara Instrument, Inc.
Sources (2)
- FDA 510(k) K161465 24 fields · synced Jun 18, 2026
- FDA UDI 2d4d7f1e-b938-4824-a5ec-c7ccc9da663c 35 fields · synced May 27, 2026