Zio AT ECG Monitoring System
K-Number: K163512 · 2017-06-02
ApplicantiRhythm Technologies, Inc.
Decision Date2017-06-02
Product CodeQYX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Zio AT ECG Monitoring System is a medical device manufactured by iRhythm Technologies, Inc.. It received FDA 510(k) clearance on 2017-06-02 under approval number K163512. 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 Zio AT ECG Monitoring System?
Zio AT ECG Monitoring System is a medical device that received FDA 510(k) clearance on 2017-06-02. It is manufactured by iRhythm Technologies, Inc.. The 510(k) number is K163512.
When was Zio AT ECG Monitoring System approved by the FDA?
Zio AT ECG Monitoring System received FDA 510(k) clearance on 2017-06-02, under approval number K163512.
What company makes Zio AT ECG Monitoring System?
Zio AT ECG Monitoring System is manufactured by iRhythm Technologies, Inc..
What is the FDA product code for Zio AT ECG Monitoring System?
The FDA product code for Zio AT ECG Monitoring System is QYX.
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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.