EK12 V2 Algorithm
K-Number: K221904 · 2022-12-20
Decision Date2022-12-20
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
EK12 V2 Algorithm is a medical device manufactured by Ge Medical Systems Information Technologies, Inc.. It received FDA 510(k) clearance on 2022-12-20 under approval number K221904. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EK12 V2 Algorithm?
EK12 V2 Algorithm is a medical device that received FDA 510(k) clearance on 2022-12-20. It is manufactured by Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K221904.
When was EK12 V2 Algorithm approved by the FDA?
EK12 V2 Algorithm received FDA 510(k) clearance on 2022-12-20, under approval number K221904.
What company makes EK12 V2 Algorithm?
EK12 V2 Algorithm is manufactured by Ge Medical Systems Information Technologies, Inc..
What is the FDA product code for EK12 V2 Algorithm?
The FDA product code for EK12 V2 Algorithm is MHX.
Other Devices by Ge Medical Systems Information Technologies, Inc.
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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.