ZEUS System
K-Number: K222389 · 2023-02-15
ApplicantiRhythm Technologies, Inc.
Decision Date2023-02-15
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
ZEUS System is a medical device manufactured by iRhythm Technologies, Inc.. It received FDA 510(k) clearance on 2023-02-15 under approval number K222389. 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 ZEUS System?
ZEUS System is a medical device that received FDA 510(k) clearance on 2023-02-15. It is manufactured by iRhythm Technologies, Inc.. The 510(k) number is K222389.
When was ZEUS System approved by the FDA?
ZEUS System received FDA 510(k) clearance on 2023-02-15, under approval number K222389.
What company makes ZEUS System?
ZEUS System is manufactured by iRhythm Technologies, Inc..
What is the FDA product code for ZEUS System?
The FDA product code for ZEUS System 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.