MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System
K-Number: K160064 · 2016-03-11
ApplicantInfobionic, Inc.
Decision Date2016-03-11
Product CodeQYX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System is a medical device manufactured by Infobionic, Inc.. It received FDA 510(k) clearance on 2016-03-11 under approval number K160064. The device is classified under product code QYX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System?
MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System is a medical device that received FDA 510(k) clearance on 2016-03-11. It is manufactured by Infobionic, Inc.. The 510(k) number is K160064.
When was MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System approved by the FDA?
MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System received FDA 510(k) clearance on 2016-03-11, under approval number K160064.
What company makes MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System?
MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System is manufactured by Infobionic, Inc..
What is the FDA product code for MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System?
The FDA product code for MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System is QYX.
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Official Source
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