Identifiers
- 510(k) Number
- K191406 FDA 510(k)
- FDA Product Code
- DXH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2920 FDA 510(k)
- Regulation Number
- 870.2920 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The device is a transmitter and receiver, electrocardiograph, telephone, classified as a Class II medical device under regulation number 870.2920. It is designed for cardiovascular applications and has been determined to be substantially equivalent through a traditional 510(k) clearance process.
The device is manufactured by AliveCor, Inc. and received FDA 510(k) clearance under K-number K191406. It is supplied as a non-sterile, reusable system intended for use in clinical settings by trained medical professionals to record patient ECG data. No information regarding sterility, single-use status, MRI safety, sizes, or storage conditions is provided in the data.
Frequently asked questions
What is the KardiaMobile KardiaStation used for?
The KardiaMobile KardiaStation is designed for cardiovascular applications and is used to record patient ECG data in clinical settings by trained medical professionals.
Is the KardiaMobile KardiaStation sterile or single-use?
The device is supplied as a non-sterile, reusable system, meaning it is not sterile and is intended for multiple uses after appropriate cleaning and disinfection between patients.
Who manufactures the KardiaMobile KardiaStation and what is its regulatory pathway?
The KardiaMobile KardiaStation is manufactured by AliveCor, Inc. and received FDA 510(k) clearance under K-number K191406 through a traditional 510(k) process, demonstrating substantial equivalence to a predicate device.
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. Sources consulted: KardiaStation | AliveCor, AliveCor | AliveCor Home, Personal EKG Devices by AliveCor - AliveCor, Inc., KardiaStation - Apps on Google Play
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191406 | Class II | Active |
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Manufacturer
- Manufacturer
- Alivecor, Inc.
Sources (1)
- FDA 510(k) K191406 24 fields · synced Sep 26, 2026