EK12 Algorithm
K-Number: K170155 · 2017-06-06
Decision Date2017-06-06
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
EK12 Algorithm is a medical device manufactured by Ge Medical Systems Information Technologies, Inc.. It received FDA 510(k) clearance on 2017-06-06 under approval number K170155. 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 Algorithm?
EK12 Algorithm is a medical device that received FDA 510(k) clearance on 2017-06-06. It is manufactured by Ge Medical Systems Information Technologies, Inc.. The 510(k) number is K170155.
When was EK12 Algorithm approved by the FDA?
EK12 Algorithm received FDA 510(k) clearance on 2017-06-06, under approval number K170155.
What company makes EK12 Algorithm?
EK12 Algorithm is manufactured by Ge Medical Systems Information Technologies, Inc..
What is the FDA product code for EK12 Algorithm?
The FDA product code for EK12 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.