Identifiers
- 510(k) Number
- K181823 FDA 510(k)
- FDA Product Code
- DQK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1425 FDA 510(k)
- Regulation Number
- 870.1425 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
KardiaAI is a device that provides analysis of electrocardiogram data. It is designed to assist in the interpretation of cardiac rhythm patterns.
The device is supplied by Alivecor, Inc. and is authorized under FDA 510K clearance. It is intended for use in cardiovascular settings and is regulated under product code DQK.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
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 | K181823 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alivecor, Inc.
Sources (1)
- FDA 510(k) K181823 24 fields · synced Sep 23, 2026