KardiaAI
K-Number: K181823 · 2019-03-11
ApplicantAliveCor, Inc.
Decision Date2019-03-11
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
KardiaAI is a medical device manufactured by AliveCor, Inc.. It received FDA 510(k) clearance on 2019-03-11 under approval number K181823. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the KardiaAI?
KardiaAI is a medical device that received FDA 510(k) clearance on 2019-03-11. It is manufactured by AliveCor, Inc.. The 510(k) number is K181823.
When was KardiaAI approved by the FDA?
KardiaAI received FDA 510(k) clearance on 2019-03-11, under approval number K181823.
What company makes KardiaAI?
KardiaAI is manufactured by AliveCor, Inc..
What is the FDA product code for KardiaAI?
The FDA product code for KardiaAI is DQK.
Other Devices by AliveCor, Inc.
Related Devices (Code: DQK)
K160218AutoMark ModuleSt Jude Medical
K160210EnSite Precision Cardiac Mapping System v2.0St Jude Medical
K162643MediGuide Technology SystemSt Jude Medical
K162440CardioInsight Cardiac Mapping SystemCardioinsight Technologies, Inc.
K160187Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0St Jude Medical
K160186EnSite Velocity Surface Electrode KitSt Jude Medical
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.