Zio Monitor
K-Number: K202359 · 2021-05-21
ApplicantiRhythm Technologies, Inc.
Decision Date2021-05-21
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Zio Monitor is a medical device manufactured by iRhythm Technologies, Inc.. It received FDA 510(k) clearance on 2021-05-21 under approval number K202359. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Zio Monitor?
Zio Monitor is a medical device that received FDA 510(k) clearance on 2021-05-21. It is manufactured by iRhythm Technologies, Inc.. The 510(k) number is K202359.
When was Zio Monitor approved by the FDA?
Zio Monitor received FDA 510(k) clearance on 2021-05-21, under approval number K202359.
What company makes Zio Monitor?
Zio Monitor is manufactured by iRhythm Technologies, Inc..
What is the FDA product code for Zio Monitor?
The FDA product code for Zio Monitor is DSH.
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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.