KardiaMobile, KardiaStation
K-Number: K191406 · 2020-01-24
ApplicantAliveCor, Inc.
Decision Date2020-01-24
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
KardiaMobile, KardiaStation is a medical device manufactured by AliveCor, Inc.. It received FDA 510(k) clearance on 2020-01-24 under approval number K191406. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the KardiaMobile, KardiaStation?
KardiaMobile, KardiaStation is a medical device that received FDA 510(k) clearance on 2020-01-24. It is manufactured by AliveCor, Inc.. The 510(k) number is K191406.
When was KardiaMobile, KardiaStation approved by the FDA?
KardiaMobile, KardiaStation received FDA 510(k) clearance on 2020-01-24, under approval number K191406.
What company makes KardiaMobile, KardiaStation?
KardiaMobile, KardiaStation is manufactured by AliveCor, Inc..
What is the FDA product code for KardiaMobile, KardiaStation?
The FDA product code for KardiaMobile, KardiaStation is DXH. This falls under the Hematology category.
Other Devices by AliveCor, Inc.
Related Devices (Code: DXH)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.