KardiaMobile Card
K-Number: K211668 · 2021-11-30
ApplicantAliveCor, Inc.
Decision Date2021-11-30
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
KardiaMobile Card is a medical device manufactured by AliveCor, Inc.. It received FDA 510(k) clearance on 2021-11-30 under approval number K211668. 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 Card?
KardiaMobile Card is a medical device that received FDA 510(k) clearance on 2021-11-30. It is manufactured by AliveCor, Inc.. The 510(k) number is K211668.
When was KardiaMobile Card approved by the FDA?
KardiaMobile Card received FDA 510(k) clearance on 2021-11-30, under approval number K211668.
What company makes KardiaMobile Card?
KardiaMobile Card is manufactured by AliveCor, Inc..
What is the FDA product code for KardiaMobile Card?
The FDA product code for KardiaMobile Card 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.