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FDA 510(k), K182396, KardiaMobile, KardiaStation
FDA 510(k), K182396, KardiaMobile, KardiaStation
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$149.00 USD
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510(K) Number: K182396
Device Name: KardiaMobile, KardiaStation
Manufacturer: AliveCor, Inc.
Device Classification Name: transmitters and receivers, electrocardiograph, telephone
Regulation Number: 870.2920
Classification Product Code: DXH
Date Received: 09/04/2018
Decision Date: 04/12/2019
Regulation Medical Specialty: Cardiovascular
Device Name: KardiaMobile, KardiaStation
Manufacturer: AliveCor, Inc.
Device Classification Name: transmitters and receivers, electrocardiograph, telephone
Regulation Number: 870.2920
Classification Product Code: DXH
Date Received: 09/04/2018
Decision Date: 04/12/2019
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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