KardiaAI
K-Number: K201985 · 2020-11-12
ApplicantAliveCor, Inc.
Decision Date2020-11-12
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
KardiaAI is a medical device manufactured by AliveCor, Inc.. It received FDA 510(k) clearance on 2020-11-12 under approval number K201985. 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 2020-11-12. It is manufactured by AliveCor, Inc.. The 510(k) number is K201985.
When was KardiaAI approved by the FDA?
KardiaAI received FDA 510(k) clearance on 2020-11-12, under approval number K201985.
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.
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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.