KardiaMobile 6L
K-Number: K220350 · 2022-05-25
ApplicantAliveCor, Inc.
Decision Date2022-05-25
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
KardiaMobile 6L is a medical device manufactured by AliveCor, Inc.. It received FDA 510(k) clearance on 2022-05-25 under approval number K220350. 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 6L?
KardiaMobile 6L is a medical device that received FDA 510(k) clearance on 2022-05-25. It is manufactured by AliveCor, Inc.. The 510(k) number is K220350.
When was KardiaMobile 6L approved by the FDA?
KardiaMobile 6L received FDA 510(k) clearance on 2022-05-25, under approval number K220350.
What company makes KardiaMobile 6L?
KardiaMobile 6L is manufactured by AliveCor, Inc..
What is the FDA product code for KardiaMobile 6L?
The FDA product code for KardiaMobile 6L 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.